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SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial

ConditionHeart Failure With Preserved Ejection Fraction
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Empagliflozin + Potassium Chloride

    Drug

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

  • Empagliflozin + Potassium Nitrate

    Drug

    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.

  • Potassium Chloride + Placebo for Empagliflozin

    Drug

    Active control.

Treatment groups

53 Participants
are divided into 3 treatment groups
Group A: Empagliflozin + Potassium Chloride (KCl)Active comparator 1 intervention
Group B: Empagliflozin + Potassium Nitrate (KNO3)Active comparator 1 intervention
Group C: Potassium Chloride (KCl) + Placebo for EmpaPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Submaximal Exercise Endurance

Time to exhaustion while exercising at 75% peak workload

Time frame
Week 6

Secondary outcomes

1

Intramuscular Perfusion

MRI assessment of skeletal muscle perfusion

Time frame
Week 6
2

VO2 Kinetics

Assess the impact of interventions on the kinetics of oxygen consumption (VO2 kinetics) during exercise and recovery. "On" and "Off" kinetics will be modeled during the submaximal exercise transient.

Time frame
Week 6
3

VO2 Efficiency

Assess the impact of interventions on the efficiency of oxygen consumed above basal metabolic rate compared to total work performed

Time frame
Week 6
4

Vasodilatory Reserve

Percent change in systemic vascular resistance (SVR) at baseline vs SVR at 4 minutes of exercise at end of each intervention period

Time frame
Week 6

Other outcomes

1

Intramyocardial Filling Pressure

Assess impact of interventions on intramyocardial filling pressures during submaximal exercise

Time frame
Week 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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