SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial
University of Pennsylvania
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).
Description
This study will test whether Empagliflozin (Empa), with and without Potassium Nitrate (KNO3), improves submaximal exercise endurance, skeletal muscle oxidative phosphorylation capacity (SkM OxPhos), intramuscular perfusion, and changes in the skeletal muscle metabolome, proteome, and respiration in participants with Heart Failure with Preserved Ejection Fraction (HFpEF).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion: 1\. NYHA Class II-III symptoms 2. Left ventricular ejection fraction \>= 50% 3. Stable medical condition for at least 2 weeks, as per investigator judgment 4. Prior or current evidence for elevated filling pressures, as evidenced by at least one of the following: a. Mitral early (E)/septal tissue annular (e') velocity ratio \> 8, in the context of a septal e' velocity \<=7 cm/s or a lateral e' \<= 10 cm/s, in addition to one of the following: i. Large left atrium (LA volume index \> 34 mL/m2) ii. Chronic loop diuretic use for control of symptoms iii. Elevated natriuretic peptides…
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.
Location
- University of Pennsylvania Health SystemPhiladelphia, Pennsylvania