Status:
COMPLETED
DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
AstraZeneca
Conditions:
Heart Failure With Preserved Ejection Fraction (HFpEF)
Eligibility:
All Genders
40-150 years
Phase:
PHASE3
Brief 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 Pre...
Eligibility Criteria
Inclusion
- Provision of signed informed consent prior to any study specific procedures
- 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 recognised guidelines on standard of care treatment for patients with HFpEF. Therapy should have been individually optimised and stable for ≥4 weeks (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/flutter).
- 6MWD≥100 metres and ≤425 metres at enrolment and randomization
Exclusion
- 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
Key Trial Info
Start Date :
April 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2020
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT03877224
Start Date
April 4 2019
End Date
July 9 2020
Last Update
November 17 2021
Active Locations (101)
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1
Research Site
Alexander City, Alabama, United States, 35010
2
Research Site
Fort Payne, Alabama, United States, 35967
3
Research Site
Beverly Hills, California, United States, 90211
4
Research Site
Torrance, California, United States, 90502