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SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial

NCT05138575 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-04-16

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Empagliflozin + Potassium Chloride

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

DRUG

Empagliflozin + 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.

DRUG

Potassium Chloride + Placebo for Empagliflozin

Active control.

Sponsors & Collaborators

Principal Investigators

  • Payman Zamani, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05138575 on ClinicalTrials.gov