Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04913805

Matching Perfusion and Metabolic Activity in HFpEF

Led by University of Pennsylvania · Updated on 2025-05-23

53

Participants Needed

1

Research Sites

289 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Matching Perfusion and Metabolic Activity in HFpEF

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • NYHA Class II-III symptoms
  • Left ventricular ejection fraction equal to or greater than 50%
  • Stable medical condition for at least 2 weeks as judged by the investigator
  • Prior or current evidence for elevated filling pressures as defined by specific heart function measurements or history, including: mitral E/e' velocity ratios, large left atrium volume, chronic loop diuretic use, elevated natriuretic peptides, elevated resting or exercise filling pressures, or prior acute heart failure requiring IV diuretics
Not Eligible

You will not qualify if you...

  • Under 18 years old
  • Pregnant
  • Currently treated with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted
  • Uncontrolled atrial fibrillation with resting heart rate over 100 beats per minute
  • Hemoglobin less than 10 g/dL
  • Unable or unwilling to exercise
  • Moderate or greater left-sided valvular heart disease, mild or greater mitral stenosis, or severe right-sided valvular disease
  • Known hypertrophic, infiltrative, or inflammatory cardiomyopathy
  • Clinically significant pericardial disease
  • Current angina due to significant coronary artery disease
  • Acute coronary syndrome or coronary intervention within past 2 months
  • Primary pulmonary artery hypertension (WHO Group 1)
  • Significant lung disease defined by severe COPD, recent steroid treatment, current oxygen use except for sleep apnea, or oxygen desaturation below 90% during exercise
  • Clinically significant ischemia without appropriate revascularization or negative follow-up stress test
  • Left ventricular ejection fraction below 45% unless due to arrhythmia and returned to normal
  • Significant liver disease affecting function or volume control
  • Kidney function with eGFR below 30 mL/min/1.73m2
  • Methemoglobin level over 5%
  • Serum potassium level above 5.0 mEq/L
  • Severe right ventricular dysfunction
  • Resting seated systolic blood pressure higher than 180 mmHg or lower than 100 mmHg
  • Persistent abnormal seated blood pressure outside 100-180 mmHg range at baseline
  • Orthostatic blood pressure drop over 20 mmHg within 2-3 minutes of standing
  • Active participation in another study with an investigational agent
  • Any condition that may interfere with study completion as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

M

Melissa Fernand, MPH

CONTACT

C

Cassandra Demastus, NP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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Matching Perfusion and Metabolic Activity in HFpEF | DecenTrialz