DETERMINE-preserved – Dapagliflozin effect on exercise capacity using a 6-minute walk test in patients with heart failure with preserved ejection fraction

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 fibrillation/flutter, 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