determine-reduced - dapagliflozin effect on exercise capacity using a 6-minute walk test in patients with heart failure with reduced ejection fraction

Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF)

Summary: 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 reduced ejection fraction (hfref)


Eligibility criteria:
inclusion criteria: * provision of signed informed consent prior to any study specific procedures * male or female, aged ≥18 years * documented diagnosis of symptomatic hfref (nyha functional class ii-iv), which has been present for at least 8 weeks * lvef≤40% * elevated nt-probnp levels * patients should receive background standard of care as described below: all hfref patients should be treated according to locally recognised guidelines on standard of care treatment with both drugs and devices, as appropriate. guideline-recommended medications should be used at recommended doses unless contraindicated or not tolerated. therapy should have been individually optimised and stable for ≥4 weeks (this does not apply to diuretics) before visit 1 and include (unless contraindicated or not tolerated): * an ace inhibitor, or arb or sacubitril/valsartan and * a beta-blocker and * if considered appropriate by the patient's treating physician; a mineral corticoid receptor antagonist * 6mwd≥100 metres and ≤425 metres at enrolment and randomization. exclusion criteria: * presence of any condition that precludes exercise testing * participation in a structured exercise training programme in the 1 month prior to screening or planned to start during the trial * receiving therapy with an sglt2 inhibitor within 4 weeks prior to enrolment or previous intolerance of an sglt2 inhibitor * type 1 diabetes mellitus * egfr \<25 ml/min/1.73 m2 (ckd-epi formula) at enrolment, unstable or rapidly progressing renal disease at time of randomisation * systolic bp \<95 mmhg on 2 consecutive measurements * systolic bp ≥160 mmhg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmhg irrespective of treatments, on 2 consecutive measurements * current acute decompensated hf or hospitalisation due to decompensated hf \<4 weeks prior to enrolment * mi, unstable angina, coronary revascularization ablation of atrial flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronization therapy device within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization. * stroke or transient ischemic attack within 12 weeks prior to enrolment. * primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including copd. * previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization * hf due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease