Heart Failure With Preserved Ejection Fraction (HFpEF)
Conditions
Interventions
investigational material(s)
Generic name etc : Dapagliflozin
INN of investigational material : dapagliflozin
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investig
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Provision of signed informed consent prior to any study specific procedures - Male or female, aged 40 years or more - 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 recognised guidelines on standard of care treatment for patients with HFpEF. Therapy should have been individually optimised and stable for 4 weeks or more (this does not apply to diuretics) and include (unless contraindicated or not tolerated) treatment of co morbidities (including high blood pressure, ischaemic heart disease, atrial fibrillation) - 6MWD 100 metres or more and 425 metres or less at enrolment and randomization
Exclusion criteria
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 or more if not on treatment with 3 blood pressure lowering medications or more 180 mmHg irrespective of treatments or more, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed