Matching Perfusion and Metabolic Activity in HFpEF
NCT04913805 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2025-05-23
Summary
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).
Conditions
Interventions
- DRUG
-
Potassium Nitrate
Potassium Nitrate is the active intervention that may increase blood flow to exercising muscle
- DRUG
-
Potassium Nitrate + Propionyl-L-Carnitine + Nicotinamide Riboside
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)
- OTHER
-
Potassium Chloride
Active control
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Payman Zamani, MD · University of Pennsylvania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-11
- Primary Completion
- 2027-05-01
- Completion
- 2027-05-01
Countries
- United States
Study Locations
More Related Trials
-
Treatment of HFpEF With Nitrate Supplement
NCT03289481 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Effect of Dapagliflozin on Submaximal Exercise Tolerance in Heart Failure
NCT04956809 ·Status: COMPLETED ·Phase: PHASE2
-
This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms
NCT03448419 ·Status: COMPLETED ·Phase: PHASE3
-
Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
NCT06581159 ·Status: TERMINATED ·Phase: PHASE1
-
BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF
NCT04434664 ·Status: COMPLETED ·Phase: PHASE4
-
Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction
NCT02262078 ·Status: COMPLETED ·Phase: PHASE2
-
This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms.
NCT03448406 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction
NCT05139615 ·Status: TERMINATED ·Phase: PHASE2
-
Inorganic NItrate and EXercise Performance in Heart Failure (iNIX-HF): Dose Response
NCT02797184 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Oral Nitrate in Adults With Pulmonary Hypertension With Heart Failure and Preserved Ejection Fraction
NCT02980068 ·Status: COMPLETED ·Phase: PHASE1
-
Chronotropic Incompetence in Patients With HFpEF
NCT02524145 ·Status: COMPLETED ·Phase: NA
-
Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction
NCT02918552 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
NCT00050076 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
NCT03357731 ·Status: COMPLETED ·Phase: PHASE2
-
Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction
NCT02053493 ·Status: COMPLETED ·Phase: PHASE2
-
Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product
NCT02804282 ·Status: COMPLETED ·Phase: PHASE3
-
The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)
NCT05562167 ·Status: RECRUITING ·Phase: PHASE2
-
Effects of Acetazolamide and CO2 Inhalation on Exercise-induced Periodic Breathing in Heart Failure
NCT00517426 ·Status: COMPLETED ·Phase: PHASE4
-
St. Vincent's Screening To Prevent Heart Failure Study
NCT00921960 ·Status: COMPLETED ·Phase: NA
-
Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study)
NCT00577135 ·Status: COMPLETED ·Phase: PHASE3
-
Novel Approaches for Improving Vascular Function in Veterans With HFpEF
NCT06312748 ·Status: RECRUITING ·Phase: PHASE1
-
Study of HS235 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT07123779 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Pilot Study for First Clinical Use of sc2Wear Furosemide Combination Product
NCT02804035 ·Status: COMPLETED ·Phase: PHASE2
-
The Re-Prosper HF Study
NCT04551222 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Short-term Effects of Dapagliflozin on Peak VO2 in HFrEF
NCT04197635 ·Status: COMPLETED ·Phase: PHASE4