DETERMINE – HFpEF

International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients With Preserved Ejection Fraction
 

Objective

The primary objective of this trial is to determine whether dapagliflozin is superior to placebo in increasing exercise capacity in patients with chronic heart failure New York Heart Association (NYHA) Functional Class II-IV and preserved ejection fraction (LVEF>40%).

Eligibility

  • Male or female, aged ≥40 years
  • Established documented diagnosis of symptomatic HFpEF (NYHA functional class II-IV), which has been present for at least 8 weeks
  • LVEF>40% and evidence of structural heart disease
  • Elevated NT-proBNP levels
  • Patients should receive background standard of care as described below: All patients will be treated according to locally recognized guidelines on standard of care treatment for patients with HFpEF. Therapy should have been individually optimized and stable for ≥4 weeks (this does not apply to diuretics) and include (unless contraindicated or not tolerated) treatment of comorbidities (including high blood pressure, ischemic heart disease, atrial fibrillation).
  • 6MWD≥100 meters and ≤425 meters at enrolment and randomization

NCT ID

NCT03877224