Clinical trials›Heart Failure With Preserved Ejection Fraction›Lifestyle›Trial details
FinishedComing Soon (1–3 yrs) Treatment Study

Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction

For Condition: Heart Failure With Preserved Ejection Fraction

ID: NCT01920711

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken
Diet & Lifestyle / Therapy Care
Expected Availability Horizon
Coming Soon (1–3 yrs away)
StageAdvanced Clinical Stage : Large-scale testing in thousands of patients. The final benchmark comparison phase closest to FDA approval and commercial release.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial

The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

Read Full Scientific Objectives & Methods

This was a multicenter, randomized, double-blind, parallel group, active-controlled, study to evaluate the efficacy and safety of sacubitril/valsartan compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction. Specifically, the study evaluated the effect of sacubitril/valsartan compared to the active comparator valsartan in the reduction of the rate of CV death and total HF hospitalizations in patients with HFpEF. The trial consisted of two periods: (1) a single-blind treatment run-in epoch that lasted from 3 to 8 weeks, in which patients received valsartan 80 mg bid, followed by sacubitril/valsartan 100 mg bid and (2) a double-blind randomized treatment epoch (sacubitril/valsartan 200 mg bid or valsartan 160 mg bid). In this study, investigators were responsible for assessing and submitting all events which could potentially fulfill the criteria for the primary, secondary, or other clinical endpoints to a Clinical Endpoint Committee (CEC). Investigator reported events were assessed by the CEC for adjudication. For angioedema or angioedema-like events, investigators completed an Adjudication Questionnaire for an Angioedema-like Event form. All angioedema reports were forwarded to an Angioedema Adjudication Committee (AAC) by Novartis for assessment.

Study Timeline & Quick Facts
Trial Status
Study Finished
Total Target Enrollment
4.8K patients (Actual)
Study Start Date
2014-07-18
Est. Primary Completion
2019-06-07
Tested Drugs & Treatment Groups
DRUGLCZ696

LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.

DRUGValsartan

Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.

Treatment Arms Description

EXPERIMENTALLCZ696

Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of LCZ696 during the double blind period is 200 mg b.i.d.

ACTIVE_COMPARATORValsartan

Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of Valsartan during the double blind period is 160 mg b.i.d.

Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
50 Years and older
Full Criteria Checklist
Who Can Join
  • Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry.
  • Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
  • Current symptom(s) of HF (NYHA class II-IV)
  • Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
  • Elevated NT-proBNP
Who Cannot Join
  • Any prior measurement of LVEF \< 40%.
  • Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
  • Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF ≥45%.
  • Current acute decompensated HF requiring therapy.
  • Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor.
  • Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) \<10 g/dl, or body mass index (BMI) \> 40 kg/m2.
  • Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP \>150 mmHg and \<180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP \< 110 mmHg at entry.
What is this Study Measuring?

Primary Outcome Measures

  • Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. — Time Frame: Total follow up time (up to 57 months)

    The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association \[NYHA\] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction \[LVEF\] ≥45%). The treatment arm with the lower rate of events will be deemed as having a successful response.

View Secondary Outcome Measures (4)
  • Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ) — Time Frame: Baseline, 8 months

    The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure (HF) patients. The clinical summary score, which is derived from the physical limitations and heart failure (HF) symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Evaluation of change from baseline to month 8 in KCCQ a most sensitive, specific, and responsive health-related quality of life measure for heart failure symptoms and physical limitations.

  • Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class — Time Frame: Baseline, 8 months

    Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a heart failure's (HF) patients' level of functionality based on the signs and symptoms of HF exhibited by the patient.

  • Participants With First Occurrence of a Composite Renal Endpoint — Time Frame: Randomization to total follow-up time (up to 57 months)

    Analyis of composite renal endpoint defined as renal death, or reaching ESRD, or ≥50% decline in eGFR relative to baseline, using Cox's proportional hazards model.

  • All-cause Mortality — Time Frame: Randomization to total follow up time (up to 57 months)

    Analysis for all-cause mortality using Cox's proportional hazards model.

Where to Participate

This trial is recruiting at 715 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 715 Facilities & Contact Sites
Novartis Investigative Site
Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Muscle Shoals, Alabama, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Orange, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Denver, Colorado, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Stamford, Connecticut, United States
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West Haven, Connecticut, United States
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Bradenton, Florida, United States
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Gainesville, Florida, United States
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Lake Worth, Florida, United States
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Miami, Florida, United States
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Tallahassee, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Covington, Georgia, United States
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Cumming, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Hazel Crest, Illinois, United States
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Lombard, Illinois, United States
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Maywood, Illinois, United States
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Oakbrook Terrace, Illinois, United States
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Peoria, Illinois, United States
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Quincy, Illinois, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Hammond, Louisiana, United States
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Lafayette, Louisiana, United States
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Slidell, Louisiana, United States
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Biddeford, Maine, United States
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Portland, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Grand Blanc, Michigan, United States
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Saginaw, Michigan, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Saint Paul, Minnesota, United States
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Belzoni, Mississippi, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Lincoln, Nebraska, United States
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Lebanon, New Hampshire, United States
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Morristown, New Jersey, United States
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New Brunswick, New Jersey, United States
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Ridgewood, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Flushing, New York, United States
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Kingston, New York, United States
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Northport, New York, United States
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Rochester, New York, United States
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Saratoga Springs, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Grand Forks, North Dakota, United States
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Canton, Ohio, United States
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Marion, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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Providence, Rhode Island, United States
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Warwick, Rhode Island, United States
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Charleston, South Carolina, United States
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Rapid City, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Beaumont, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Livingston, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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White River Junction, Vermont, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Ramos Mejía, Buenos Aires, Argentina
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CABA, Buenos Aires F.D., Argentina
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Posadas, Misiones Province, Argentina
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Salta, Salta Province, Argentina
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San Miguel de Tucumán, San Miguel de Tucuman, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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CABA, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Formosa, Argentina
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San Luis, Argentina
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Santa Fe, Argentina
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Southport, Queensland, Australia
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Bedford Park, South Australia, Australia
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Bundoora, Victoria, Australia
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Epping, Victoria, Australia
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Geelong, Victoria, Australia
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Innsbruck, Tyrol, Austria
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Braunau am Inn, Austria
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Graz, Austria
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Grossgmain, Austria
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Linz, Austria
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Vienna, Austria
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Aalst, Belgium
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Antwerp, Belgium
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Brasschaat, Belgium
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Brussels, Belgium
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De Pinte, Belgium
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Genk, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Huy, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Ottignies, Belgium
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Goiânia, Goiás, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Uberlândia, Minas Gerais, Brazil
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Campina Grande do Sul, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Blumenau, Santa Catarina, Brazil
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Campinas, São Paulo, Brazil
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Campinas, São Paulo, Brazil
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Liberdade, São Paulo, Brazil
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Ribeirão Preto, São Paulo, Brazil
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São José do Rio Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Smolyan, Bulgaria, Bulgaria
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Burgas, Bulgaria
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Pazardzhik, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Plovdiv, Bulgaria
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Shumen, Bulgaria
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Silistra, Bulgaria
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Sliven, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria
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Calgary, Alberta, Canada
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Victoria, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Cambridge, Ontario, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Weston, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Thetford-Mines, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Chongqing, Chongqing Municipality, China
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Lanzhou, Gansu, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Nanning, Guangxi, China
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Changsha, Hunan, China
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Wuxi, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Jilin City, Jilin, China
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Shenyang, Liaoning, China
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Shenyang, Liaoning, China
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Shanghai, Shanghai Municipality, China
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Shanghai, Shanghai Municipality, China
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Shanghai, Shanghai Municipality, China
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Xian, Shanxi, China
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Xi’an, Shanxi, China
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Chengdu, Sichuan, China
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Tianjin, Tianjin Municipality, China
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Ürümqi, Xinjiang, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Beijing, China
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Beijing, China
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Chongqing, China
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Jinan, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Shanghai, China
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Barranquilla, Colombia
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Barranquilla, Colombia
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Florida Blanca, Colombia
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Varaždin, HRV, Croatia
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Rijeka, Croatia
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Zadar, Croatia
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Zagreb, Croatia
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Brandýs nad Labem, Czech Republic, Czechia
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Brno, Czech Republic, Czechia
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Ivančice, Czech Republic, Czechia
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Kladno, Czech Republic, Czechia
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Liberec, Czech Republic, Czechia
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Louny, Czech Republic, Czechia
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Ostrava, Czech Republic, Czechia
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Pilsen, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Rožnov pod Radhoštěm, Czech Republic, Czechia
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Svitavy, Czech Republic, Czechia
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Třebíč, Czech Republic, Czechia
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Ústí nad Labem, Czech Republic, Czechia
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Znojmo, Czech Republic, Czechia
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Policska, CZE, Czechia
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Prague, CZE, Czechia
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Ústí nad Labem, CZE, Czechia
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CZE, Czechia
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Kolín, Czechia
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Mariánské Lázně, Czechia
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Uherské Hradiště, Czechia
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Esbjerg, Denmark
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Glostrup Municipality, Denmark
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Herlev, Denmark
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Hvidovre, Denmark
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Randers, Denmark
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Svendborg, Denmark
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Viborg, Denmark
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Jyväskylä, Finland
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Oulu, Finland
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Tampere, Finland
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Bayonne, Bayonne Cedex, France
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Montpellier, Herault, France
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Besançon, France
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Béziers, France
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Bordeaux, France
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Grenoble, France
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Lyon, France
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Paris, France
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Poitiers, France
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Pontoise, France
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Rennes, France
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Toulouse, France
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Tourcoing, France
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Vandœuvre-lès-Nancy, France
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Dresden, Saxony, Germany
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Aachen, Germany
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Bad Homburg, Germany
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Bad Krozingen, Germany
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Bamberg, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Buch, Germany
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Chemnitz, Germany
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Chemnitz, Germany
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Cologne, Germany
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Dessau, Germany
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Dresden, Germany
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Dresden, Germany
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Dresden, Germany
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Duisburg, Germany
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Eilenburg, Germany
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Elsterwerda, Germany
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Essen, Germany
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Frankfurt, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hamburg, Germany
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Hamburg, Germany
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Hamburg, Germany
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Haßloch, Germany
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Heidenau, Germany
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Heppenheim an der Bergstrasse, Germany
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Homburg, Germany
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Ingelheim, Germany
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Jena, Germany
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Kassel, Germany
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Kleve, Germany
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Koblenz, Germany
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Leipzig, Germany
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Löhne, Germany
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Ludwigshafen, Germany
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Lüneburg, Germany
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Mainz, Germany
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Meißen, Germany
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Memmingen, Germany
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Muehldorf Am Inn, Germany
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Munich, Germany
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Mühldorf, Germany
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München, Germany
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Münster, Germany
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Nienburg, Germany
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Northeim, Germany
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Oschatz, Germany
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Papenburg, Germany
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Reinfeld, Germany
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Riesa, Germany
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Rodgau, Germany
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Siegen, Germany
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Ulm, Germany
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Wermsdorf, Germany
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Weyhe, Germany
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Witten, Germany
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Wittenberg, Germany
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Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
parallel
Primary Purpose
treatment
Masking
double (participant, investigator)
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Novartis Pharmaceuticals
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Scientific Literature & Publications
  • Lu H, Claggett BL, Ostrominski JW, Pfeffer MA, Pitt B, Jhund PS, McMurray JJV, Solomon SD, Desai AS, Vaduganathan M. Time in blood pressure range and cardiovascular outcomes in HFmrEF/HFpEF: a pooled participant-level analysis of four large-scale trials. Eur J Heart Fail. 2026 Aug 30:xuag245. doi: 10.1093/ejhf/xuag245. Online ahead of print.PubMed ↗
  • Yang M, Henderson AD, Anand IS, Desai AS, Lam CSP, Maggioni AP, Martinez FA, Rouleau JL, Swedberg K, Vaduganathan M, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Rizkala A, Lewis EF, Jhund PS, Solomon SD, McMurray JJV. Sacubitril/valsartan and quality of life assessed using the EuroQol Five-dimension Three-level questionnaire level sum score (EQ-5D-3L-LSS) in patients with HFrEF and HFmrEF/HFpEF. Eur Heart J Cardiovasc Pharmacother. 2025 Nov 4;11(7):574-589. doi: 10.1093/ehjcvp/pvaf064.PubMed ↗
  • Lu H, Claggett BL, Minamisawa M, Ostrominski JW, Foa A, Pabon MA, Kalayci A, Vaduganathan M, Cikes M, Shah AM, Desai AS, McMurray JJV, Jhund PS, Packer M, Lefkowitz M, Rouleau JL, Zile MR, Zannad F, Hegde SM, Solomon SD, Skali H. Prognostic Significance of Nutritional Scores in Patients With Heart Failure: Insights From the PARAGON-HF Trial. J Am Heart Assoc. 2025 May 6;14(9):e038872. doi: 10.1161/JAHA.124.038872. Epub 2025 Apr 23.PubMed ↗
  • Kondo T, Jhund PS, Anand IS, Claggett BL, Desai AS, Docherty KF, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez FA, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Effects of Sacubitril/Valsartan According to Natriuretic Peptide Levels in Patients Enrolled in PARADIGM-HF and PARAGON-HF. JACC Heart Fail. 2025 Jun;13(6):927-939. doi: 10.1016/j.jchf.2024.12.010. Epub 2025 Mar 12.PubMed ↗
  • Peikert A, Vaduganathan M, Claggett BL, Kulac IJ, Litwin S, Zile M, Desai AS, Jhund PS, Butt JH, Lam CSP, Martinez F, Van Veldhuisen DJ, Zannad F, Rouleau J, Lefkowitz M, McMurray JJV, Solomon SD, Packer M. Near-universal prevalence of central adiposity in heart failure with preserved ejection fraction: the PARAGON-HF trial. Eur Heart J. 2025 Jul 1;46(25):2372-2390. doi: 10.1093/eurheartj/ehaf057.PubMed ↗
View Official Medical/Scientific Title

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)