Effect of Dapagliflozin on Submaximal Exercise Tolerance in Heart Failure

Conditions

• HFrEF

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dapagliflozin 10Mg Tab — DRUG
  This will be a single-center randomized, placebo controlled, double-blind, 2-treatment, 2-phase cross-over trial in 27 HFrEF subjects: (A) Dapa 10 mg daily; (B) Placebo.
• Placebo — DRUG
  This will be a single-center randomized, placebo controlled, double-blind, 2-treatment, 2-phase cross-over trial in 27 HFrEF subjects: (A) Dapa 10 mg daily; (B) Placebo.

Study Details

This study will examine whether and how the FDA-approved drug dapagliflozin (Dapa) improves submaximal exercise endurance and skeletal muscle oxidative phosphorylation capacity (SkM OxPhos) in patients with heart failure and reduced left ventricular ejection fraction (HFrEF).

Key Dates

Start date

Oct 22, 2021

Status verified

Dec 2023

Primary completion

Jun 1, 2023

Completion

Jun 1, 2023

Study Design

Enrollment

3 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: Dapagliflozin 10mg
  Active arm will be 6 weeks in duration, separated by a 2-week wash-out period.
• Placebo Comparator: Placebo
  Placebo arm will be 6 weeks in duration, separated by a 2-week wash-out period.

Primary Outcome Measure

The primary endpoint will be the change in submaximal exercise endurance (time to exhaustion at 75% of peak workload) between Dapa and placebo. [ Time Frame: 24 Months ]

Locations (1)

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