SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05138575
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Jan 24, 2022
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
53 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empagliflozin + Potassium Chloride (KCl)
    Empagliflozin (10 mg daily) + Potassium Chloride (6 mmol three times daily) Active arm will be 6 weeks in duration followed by a 2 week washout period.
  • Active Comparator: Empagliflozin + Potassium Nitrate (KNO3)
    Empagliflozin (10 mg daily) + Potassium Nitrate (6 mmol three times daily) Active arm will be 6 weeks in duration followed by a 2 week washout period.
  • Placebo Comparator: Potassium Chloride (KCl) + Placebo for Empa
    Potassium Chloride (6 mmol three times daily) + Placebo for Empagliflozin Placebo arm will be 6 weeks in duration followed by a 2 week washout period.

Primary Outcome Measure

Submaximal Exercise Endurance [ Time Frame: Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104
Cassandra J Demastus
[email protected]

Find similar trials in Philadelphia, PA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
University of Pennsylvania Health System· Philadelphia, PA

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