Health TrialsbyHealthPanel

Matching Perfusion and Metabolic Activity in HFpEF

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 increase perfusion \[Potassium Nitrate (KNO3)\], with and without additional supplements that may improve mitochondrial function \[Propionyl-L-Carnitine (PLC) and Nicotinamide Riboside (NR)\], 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

NYHA Class II-III symptoms

Left ventricular ejection fraction >= 50%

Stable medical condition for at least 2 weeks, as per investigator judgment

Disqualifiers

Age <18 years old

Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted

Uncontrolled atrial fibrillation, as defined by a resting heart rate > 100 beats per minute at the time of the baseline assessment

Hemoglobin < 10 g/dL

Trial design

Design model

Crossover

Treatments tested in this trial

  • Potassium Nitrate

    Drug

    Potassium Nitrate is the active intervention that may increase blood flow to exercising muscle

  • Potassium Nitrate + Propionyl-L-Carnitine + Nicotinamide Riboside

    Drug

    Potassium Nitrate + Propionyl-L-Carnitine + Nicotinamide Riboside will be used as a combination intervention to both increase blood flow (KNO3) and mitochondrial function (PLC + NR)

  • Potassium Chloride

    Other intervention

    Active control

Treatment groups

53 Participants
are divided into 3 treatment groups
Group A: Potassium NitrateActive comparator 1 intervention
Group B: Potassium Nitrate + Propionyl-L-Carnitine + Nicotinamide RibosideActive comparator 1 intervention
Group C: Potassium ChloridePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Submaximal Exercise Endurance

Time to exhaustion while exercising at 75% of peak workload

Time frame
week 6

Secondary outcomes

1

Skeletal muscle oxidative capacity

MRI assessment of skeletal muscle oxidative phosphorylation capacity

Time frame
week 6
2

Vasodilatory Reserve

Percent change in systemic vascular resistance at baseline vs exhaustion

Time frame
week 6
3

Kansas City Cardiomyopathy Questionnaire Overall Summary Score

Assess the impact of our interventions on quality of life

Time frame
week 6
4

VO2 Kinetics

Assess the impact of our 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

Other outcomes

1

Change in Skeletal Muscle Oxidative Capacity

The change in MRI skeletal muscle oxidative phosphorylation capacity between assessments while breathing room air versus 100% inspired oxygen

Time frame
<4 hours in between MRIs

Sponsors and contacts

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

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
Apply now