SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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 criteria
Qualifiers
None
Disqualifiers
Age <18 years old
Pregnancy: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.
Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted
Uncontrolled atrial fibrillation, as defined by a resting atrial fibrillation heart rate > 100 beats per minute at the time of the baseline assessment
Trial design
Treatments tested in this trial
- Empagliflozin + Potassium Chloride
- Empagliflozin + Potassium Nitrate
- Potassium Chloride + Placebo for Empagliflozin
Treatment groups
53 Participants
are divided into 3 treatment groupsLocations
1University of Pennsylvania Health System19104, PhiladelphiaPennsylvania, United States
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
Source ClinicalTrials.gov