RecruitingPhase 2NCT05138575

SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial

Sponsor

University of Pennsylvania

Enrollment

53 participants

Start Date

Jan 24, 2022

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Preserved Ejection Fraction

Summary

This study will test whether pharmacologic agents that may improve mitochondrial function and energy fuel metabolism \[Empagliflozin (Empa)\], with and without additional supplements that increase perfusion and fatty acid oxidation \[Potassium Nitrate (KNO3)\], improve submaximal exercise endurance and skeletal muscle oxidative phosphorylation capacity (SkM OxPhos) in participants with Heart Failure with Preserved Ejection Fraction (HFpEF).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a diabetes drug (SGLT2 inhibitor) with a natural nitrate supplement (potassium nitrate, KNO3) can improve exercise capacity and heart function in people with heart failure with preserved ejection fraction (HFpEF) — a type of heart failure where the heart pumps adequately but is too stiff. **You may be eligible if...** - You have heart failure symptoms (NYHA Class II–III: mild to moderate breathlessness) - Your heart pumps with an ejection fraction of 50% or more - Your condition has been stable for at least 2 weeks - You have evidence of elevated pressure inside your heart (shown by imaging, diuretic use, or elevated heart failure blood markers) **You may NOT be eligible if...** - Your heart failure ejection fraction is below 50% - Your condition is unstable - You do not meet echo or lab criteria for elevated filling pressures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin + Potassium Chloride

Empagliflozin is the active intervention that may improve mitochondrial function and energy fuel metabolism in skeletal muscle. KCl is an active control.

DRUGEmpagliflozin + Potassium Nitrate

Empagliflozin + KNO3 is the active intervention that may improve mitochondrial function and energy fuel metabolism in skeletal muscle, as well as increase skeletal muscle perfusion during exercise.

DRUGPotassium Chloride + Placebo for Empagliflozin

Active control.