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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6,263
10 mg tablets given once daily, per oral use.
Placebo matching dapagliflozin 10 mg
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
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.
Time frame: Up to 42.1 months
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
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.
Time frame: Up to 42.1 months
Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit)
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.
Time frame: Up to 42.1 months
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
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.
Time frame: Up to 42.1 months
Change From Baseline in the KCCQ Total Symptom Score at 8 Months
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Research Site
Fairhope, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Sheffield, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Beverly Hills, California, United States
Research Site
Loma Linda, California, United States
Research Site
Los Angeles, California, United States
Research Site
Stamford, Connecticut, United States
Research Site
Clearwater, Florida, United States
...and 338 more locations
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.
Time frame: Baseline and 8 months or death before 8 months
Subjects Included in the Endpoint of Cardiovascular Death
Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.
Time frame: Up to 42.1 months
Subjects Included in the Endpoint of All-cause Mortality
Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.
Time frame: Up to 42.1 months