Last updated on November 2019

DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Reduced Ejection Fraction

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart Failure With Reduced Ejection Fraction
  • Age: Between 18 - 150 Days
  • Gender: Male or Female

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
  • LVEF40%
  • 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 antagonis
  • 6MWD100 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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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