Matching Perfusion and Metabolic Activity in HFpEF

Who is this study for? Patients with heart failure with preserved ejection fraction
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• NYHA Class II-III symptoms

• Left ventricular ejection fraction \>= 50%

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

• Prior or current evidence for elevated filling pressures as follows:

• a. Mitral early (E)/mitral septal tissue annular (e') velocity ratio \> 8, in the context of a septal e' velocity \<=7, in addition to one of the following: i. Large left atrium (LA volume index \> 34 mL/m2) ii. Chronic loop diuretic use for control of symptoms iii. Elevated natriuretic peptides within the past year (e.g. NTproBNP \> 125 pg/mL in sinus rhythm or \> 375 pg/mL if in atrial fibrillation) b. Mitral E/e' ratio \> 14 at rest or during exercise c. Elevated invasively-determined filling pressures previously (resting left ventricular end-diastolic pressure \>= 16 mm Hg or pulmonary capillary wedge pressure \>= 15 mmHg; or PCWP/LVEDP \>= 25 mmHg with exercise) d. Prior episode of acute heart failure requiring IV diuretics

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Melissa Fernand, MPH
fernand@pennmedicine.upenn.edu
2672536141
Backup
Cassandra Demastus, NP
Cassandra.Demastus@Pennmedicine.upenn.edu
4432719022
Time Frame
Start Date: 2021-10-11
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 53
Treatments
Active_comparator: Potassium Nitrate
Potassium Nitrate (KNO3) 6 mmol three times daily
Active_comparator: Potassium Nitrate + Propionyl-L-Carnitine + Nicotinamide Riboside
Potassium Nitrate (KNO3) 6 mmol three times daily + Propionyl-L-Carnitine (PLC) 1000 mg twice daily + Nicotinamide Riboside (NR) 300 mg three times daily
Placebo_comparator: Potassium Chloride
Potassium Chloride (KCl) 6 mmol three times daily
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov