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RECRUITING Phase 2

SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial

NCT05138575 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 53 participants
Start Date 2022-01-24
Est. Completion 2026-03-01
Phase Phase 2

Sponsor

University of Pennsylvania

1,457 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05138575

The ClinicalTrials.gov registry entry for NCT05138575 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05138575 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05138575?

This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial