Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure (DAPA-HF)
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|ClinicalTrials.gov Identifier: NCT03036124|
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : September 1, 2020
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)||Drug: Dapagliflozin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4744 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Study 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|
|Actual Study Start Date :||February 8, 2017|
|Actual Primary Completion Date :||July 17, 2019|
|Actual Study Completion Date :||July 17, 2019|
Patients will be randomized 1:1 to either dapagliflozin or placebo.
10 mg or 5 mg tablets given once daily, per oral use.
Placebo Comparator: Placebo
Placebo matching dapagliflozin.
Placebo matching dapagliflozin 10 mg or 5 mg.
- 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 27.8 months. ]Primary efficacy
- Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. [ Time Frame: Up to 27.8 months. ]Secondary
- Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death. [ Time Frame: Up to 27.8 months. ]Secondary
- Change From Baseline in the KCCQ Total Symptom Score [ 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 Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death. [ Time Frame: Up to 27.8 months. ]Secondary
- Subjects Included in the Endpoint of All-cause Mortality. [ Time Frame: Up to 27.8 months. ]Secondary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036124