Phase 3
Completed N=6,263
Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
Source: ClinicalTrials.gov NCT03619213 ↗Enrolled (actual)
6,263
Serious AEs
47.4%
Results posted
Jul 2023
Primary outcomePrimary: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. — 512; 610 Participants — p=0.0008
◆ Published Evidence
Emerging
13citations · ~13 / year
EuroQol 5-Dimension Questionnaire in Heart Failure With Reduced, Mildly Reduced, and Preserved Ejection Fraction: A Patient-Level Analysis of DAPA-HF and DELIVER.
Summary
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.
Linked Publications (5)
-
EuroQol 5-Dimension Questionnaire in Heart Failure With Reduced, Mildly Reduced, and Preserved Ejection Fraction: A Patient-Level Analysis of DAPA-HF and DELIVER.
-
Severe Heart Failure and Treatment With Dapagliflozin Across the Ejection Fraction Spectrum: DAPA-HF and DELIVER.
-
Natriuretic Peptides, Body Mass Index, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction.
-
Survival Odds to Minimize Risk Heterogeneity Bias in Heart Failure Trials: Application to Dapagliflozin.
-
Achieved Ejection Fraction and Effects of Dapagliflozin in Heart Failure With Improved Ejection Fraction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. |
512; 610 | 0.0008 sig |
| PRIMARY 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 |
381; 440 | 0.0085 sig |
| SECONDARY Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) |
815; 1057 | 0.0003 sig |
| SECONDARY 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 |
605; 782 | 0.0017 sig |
| SECONDARY Change From Baseline in the KCCQ Total Symptom Score at 8 Months |
8.3; 5.2 | 0.0086 sig |
| SECONDARY Subjects Included in the Endpoint of Cardiovascular Death |
231; 261 | 0.1678 |
| SECONDARY Subjects Included in the Endpoint of All-cause Mortality |
497; 526 | 0.3425 |
Eligibility Criteria
Inclusion Criteria
- 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.
- Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
- 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.
Further details regarding inclusion criteria 4-6 may apply.
Exclusion Criteria
- 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 50 kg/m2.
Further exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03619213) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.