Phase 3
Completed N=4,744
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure
Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Source: ClinicalTrials.gov NCT03036124 ↗
Enrolled (actual)
4,744
Serious AEs
39.9%
Results posted
Sep 2020
Primary outcomePrimary: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. — 386; 502 Participants — p=<0.0001
◆ Published Evidence
Established
28citations · ~14 / year
Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
Summary
The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction
Linked Publications (5)
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Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
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Interleukin-6 in Heart Failure With Reduced Ejection Fraction and the Effect of Dapagliflozin: An Exploratory Analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure Trial.
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Dapagliflozin and Days of Full Health Lost in the DAPA-HF Trial.
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Cellular Adhesion Molecules and Adverse Outcomes in Chronic Heart Failure: Findings From the DAPA-HF Randomized Clinical Trial.
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Survival Odds to Minimize Risk Heterogeneity Bias in Heart Failure Trials: Application to Dapagliflozin.
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. |
386; 502 | <0.0001 sig |
| SECONDARY Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. |
382; 495 | <0.0001 sig |
| SECONDARY Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death. |
567; 742 | 0.0002 sig |
| SECONDARY Change From Baseline in the KCCQ Total Symptom Score |
6.1; 3.3 | <0.0001 sig |
| SECONDARY Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death. |
28; 39 | 0.1681 |
| SECONDARY Subjects Included in the Endpoint of All-cause Mortality. |
276; 329 | 0.0217 sig |
Eligibility Criteria
Inclusion Criteria
- Provision of signed informed consent prior to any study specific procedures
- Male or female, aged ≥18 years
- Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
- LVEF≤40%
- Elevated NT-proBNP levels
- Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
- eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
Exclusion Criteria
- Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- Type 1 diabetes mellitus
- Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
- Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
- MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
- Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
- Symptomatic bradycardia or second or third degree heart block without a pacemaker
- Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
Data sourced from ClinicalTrials.gov (NCT03036124) 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.