Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05138575 · ClinicalTrials.gov registry record · Phase 2
SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial
A Phase 2 study of Heart Failure With Preserved Ejection Fraction, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT05138575: Recruiting Phase 2 study of Heart Failure With Preserved Ejection Fraction, sponsored by University of Pennsylvania.
NCT05138575 is a Phase 2 study of Heart Failure With Preserved Ejection Fraction that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 53 participants, below the 2,287-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05138575, a Phase 2 study of Heart Failure With Preserved Ejection Fraction, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
Time to exhaustion while exercising at 75% peak workload
Conditions Studied
Interventions
- DRUG Empagliflozin + Potassium Chloride
- DRUG Empagliflozin + Potassium Nitrate
- DRUG Potassium Chloride + Placebo for Empagliflozin
Study Locations (1)
Pennsylvania
- University of Pennsylvania Health System - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 2 |
What NCT05138575 shows while recruiting
NCT05138575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 2,287-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Heart Failure With Preserved Ejection Fraction appearing as the primary indexed condition, and to 3 interventions - of which Empagliflozin + Potassium Chloride is the first listed.
NCT05138575 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05138575 about?
NCT05138575 is a clinical study titled "SGLT2i and KNO3 in HFpEF - The SAK HFpEF 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 ...
What is the current status of trial NCT05138575?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2022-01-24. Estimated completion is 2026-03-01.
What conditions does trial NCT05138575 study?
This clinical trial studies the following conditions: Heart Failure With Preserved Ejection Fraction.
What interventions are being tested in trial NCT05138575?
The interventions under investigation include: Empagliflozin + Potassium Chloride (DRUG), Empagliflozin + Potassium Nitrate (DRUG), Potassium Chloride + Placebo for Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT05138575?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05138575 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure With Preserved Ejection Fraction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05138575's enrollment target sits among peer trials
53 26th of 42 higher than 16 of 42 other Heart Failure With Preserved Ejection Fraction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure With Preserved Ejection Fraction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Matching Perfusion and Metabolic Activity in HFpEF
RECRUITING · Phase 2
-
Study of JK07 in Patients With Chronic Heart Failure
RECRUITING · Phase 2
-
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
RECRUITING · Phase 2
-
A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
RECRUITING · Phase 2
-
Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction
ACTIVE NOT RECRUITING · Phase 2
-
Cilostazol for HFpEF
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04177004 · 53 participants · Phase 1
Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant
- NCT04199741 · 53 participants · Phase 1
PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56
- NCT04835129 · 53 participants · Phase 2
Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
- NCT05045950 · 53 participants · Phase 2
Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI