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

Completed · Phase 3 · Has a placebo group

Conditions studied: Heart Failure With Reduced Ejection Fraction (HFrEF)

In brief

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 Reduced Ejection Fraction (HFrEF)

Key facts

Study ID

NCT03877237

Run by

AstraZeneca

People needed

313

Starts

2019-04-09

Expected to finish

2020-03-07

Last updated by the study team

2021-05-05

Who can join

Age: 18 and older, up to 150. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Fairhope, Alabama, United States
• Research Site — Fort Payne, Alabama, United States
• Research Site — Mobile, Alabama, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Torrance, California, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Tucker, Georgia, United States
• Research Site — Munster, Indiana, United States
• Research Site — Petoskey, Michigan, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — New Brunswick, New Jersey, United States
• Research Site — Buffalo, New York, United States
• Research Site — New York, New York, United States
• Research Site — Rosedale, New York, United States
• Research Site — Burlington, North Carolina, United States
• Research Site — Abington, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Tullahoma, Tennessee, United States
• Research Site — Falls Church, Virginia, United States
• Research Site — Seattle, Washington, United States
• Research Site — Blumenau, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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