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
This is an international, multicentre, parallel group, event-driven, randomized, double-blind, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction (HFrEF), evaluating the effect of dapagliflozin versus placebo, given once daily in addition to background regional standard of care therapy, for the prevention of cardiovascular (CV) death or reduction of heart failure (HF) events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4,744
10 mg or 5 mg tablets given once daily, per oral use.
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.
Primary efficacy
Time frame: Up to 27.8 months.
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Secondary
Time frame: Up to 27.8 months.
Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.
Secondary
Time frame: Up to 27.8 months.
Change From Baseline in the KCCQ Total Symptom Score
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 Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.
Secondary
Time frame: Up to 27.8 months.
Subjects Included in the Endpoint of All-cause Mortality.
Secondary
Time frame: Up to 27.8 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
Bakersfield, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Los Angeles, California, United States
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Palm Springs, California, United States
Research Site
Stockton, California, United States
Research Site
Torrance, California, United States
Research Site
Vista, California, United States
...and 409 more locations