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

Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.

For Condition: Heart Failure With Preserved Ejection Fraction

ID: NCT03619213

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
Pills / Oral Tablets
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

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.

Read Full Scientific Objectives & Methods

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind study in patients with HFpEF, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death and heart failure events (hospitalisations for HF or urgent HF visits). Adult patients aged ≥40 years with HFpEF (LVEF \>40% and evidence of structural heart disease) and New York Heart Association (NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for 24 hours can be randomised. It is estimated that approximately 11000 patients at approximately 400-500 sites in 20-25 countries will need to be enrolled to reach the target of approximately 6100 randomised patients.

Study Timeline & Quick Facts
Trial Status
Study Finished
Total Target Enrollment
6.3K patients (Actual)
Study Start Date
2018-08-27
Est. Primary Completion
2022-03-27
Tested Drugs & Treatment Groups
DRUGDapagliflozin (Farxiga)

10 mg tablets given once daily, per oral use.

DRUGPlacebo

Placebo matching dapagliflozin 10 mg

Treatment Arms Description

EXPERIMENTALDapagliflozin

Patients will be randomized 1:1 to either dapagliflozin or placebo.

PLACEBO_COMPARATORPlacebo

Placebo matching dapagliflozin.

Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
Between 40 Years and 130 Years
Full Criteria Checklist
Who Can Join
  • Provision of signed informed consent prior to any study specific procedures.
  • Male or female patients age ≥40 years.
  • Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
Who Cannot Join
  • Elevated NT-pro BNP levels.
  • Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.
  • Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
  • Type 1 diabetes mellitus (T1D).
  • eGFR \<25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
  • Systolic blood pressure (BP) \<95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
  • Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
  • MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
  • Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
  • Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
  • Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
  • Body mass index \>50 kg/m2.
What is this Study Measuring?

Primary Outcome Measures

  • Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. — Time Frame: Up to 42.1 months

    Dual primary efficacy Primary endpoint analysed in all patients randomised (Full analysis set). The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.

  • Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation — Time Frame: Up to 42.1 months

    Dual primary efficacy Primary endpoint analysed in all patients randomised with LVEF \< 60% at baseline. The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.

View Secondary Outcome Measures (5)
  • Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) — Time Frame: Up to 42.1 months

    Secondary efficacy Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients. The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.

  • Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation — Time Frame: Up to 42.1 months

    Secondary efficacy Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients with LVEF \< 60% at baseline The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.

  • Change From Baseline in the KCCQ Total Symptom Score at 8 Months — Time Frame: Baseline and 8 months or death before 8 months

    KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ Total Symptom Score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

  • Subjects Included in the Endpoint of Cardiovascular Death — Time Frame: Up to 42.1 months

    Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.

  • Subjects Included in the Endpoint of All-cause Mortality — Time Frame: Up to 42.1 months

    Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.

Where to Participate

This trial is recruiting at 348 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 348 Facilities & Contact Sites
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Fairhope, Alabama, United States
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Mobile, Alabama, United States
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Sheffield, Alabama, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Stamford, Connecticut, United States
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Clearwater, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Ormond Beach, Florida, United States
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Port Charlotte, Florida, United States
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Saint Augustine, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Anderson, Indiana, United States
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Munster, Indiana, United States
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Louisville, Kentucky, United States
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Hammond, Louisiana, United States
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Houma, Louisiana, United States
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Monroe, Louisiana, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Bay City, Michigan, United States
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Flint, Michigan, United States
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Flint, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Lebanon, New Hampshire, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Wilmington, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Providence, 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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Jackson, Tennessee, United States
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Beaumont, Texas, United States
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Humble, Texas, United States
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Sherman, Texas, United States
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Burlington, Vermont, United States
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Falls Church, Virginia, United States
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Leesburg, Virginia, United States
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Morgantown, West Virginia, United States
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Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aire, Argentina
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Leuven, Belgium
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Płock, Poland
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Torun, Poland
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Iași, Romania
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Moscow, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Perm, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Tver', Russia
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Dammam, Saudi Arabia
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Jeddah, Saudi Arabia
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Riyadh, Saudi Arabia
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Riyadh, Saudi Arabia
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A Coruña, Spain
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Hospitalet de Llobregat(Barcel, Spain
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Madrid, Spain
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Madrid, Spain
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Sanlúcar de Barrameda (Cádiz), Spain
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Santiago(A Coruña), Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Tainan, Taiwan
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Taoyuan City, Taiwan
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
parallel
Primary Purpose
treatment
Masking
quadruple (participant, care_provider, investigator, outcomes_assessor)
Sponsoring Teams & Contacts
Lead Sponsoring Institution
AstraZeneca
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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 ↗
  • Myte R, Mattsson A, Poole M, Little DJ, Nystrom P, Henderson A, Claggett BL, Gasparyan SB, Solomon SD, McMurray JJV. Survival Odds to Minimize Risk Heterogeneity Bias in Heart Failure Trials: Application to Dapagliflozin. Circ Heart Fail. 2025 Dec;18(12):e013496. doi: 10.1161/CIRCHEARTFAILURE.125.013496. Epub 2025 Oct 31.PubMed ↗
  • Ostrominski JW, Neuen BL, Claggett BL, Anand IS, Desai AS, Jhund PS, Lam CSP, Pfeffer MA, Pitt B, Zannad F, Zile MR, Packer M, Docherty KF, McMurray JJV, Solomon SD, Vaduganathan M. Natriuretic Peptides, Body Mass Index, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. J Am Coll Cardiol. 2025 Nov 18;86(20):1823-1839. doi: 10.1016/j.jacc.2025.08.028. Epub 2025 Aug 27.PubMed ↗
  • Siqueira SRO, Pabon MA, Vaduganathan M, Claggett BL, Lam CSP, Kosiborod MN, de Boer RA, Shah SJ, Fang JC, Desai AS, Jhund PS, Inzucchi SE, Martinez F, Hernandez AF, Petersson M, McMurray JJV, Solomon SD, Vardeny O. Achieved Ejection Fraction and Effects of Dapagliflozin in Heart Failure With Improved Ejection Fraction. JACC Heart Fail. 2025 Oct;13(10):102585. doi: 10.1016/j.jchf.2025.102585. Epub 2025 Aug 19.PubMed ↗
  • Inciardi RM, Lu H, Claggett BL, Desai AS, Jhund PS, Lam CSP, Kosiborod MN, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Kober L, Ponikowski P, Sabatine MS, Petersson M, Langkilde AM, McMurray JJV, Vaduganathan M, Solomon SD. Severe Heart Failure and Treatment With Dapagliflozin Across the Ejection Fraction Spectrum: DAPA-HF and DELIVER. JACC Heart Fail. 2025 Apr;13(4):618-627. doi: 10.1016/j.jchf.2024.11.023. Epub 2025 Mar 5.PubMed ↗
View Official Medical/Scientific Title

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)