Status:
COMPLETED
DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Reduced Ejection Fraction
Lead Sponsor:
AstraZeneca
Conditions:
Heart Failure With Reduced Ejection Fraction (HFrEF)
Eligibility:
All Genders
18-150 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 Red...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2020
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT03877237
Start Date
April 9 2019
End Date
March 7 2020
Last Update
May 5 2021
Active Locations (76)
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1
Research Site
Alexander City, Alabama, United States, 35010
2
Research Site
Fairhope, Alabama, United States, 36532
3
Research Site
Fort Payne, Alabama, United States, 35967
4
Research Site
Mobile, Alabama, United States, 36608