RECRUITING

Matching Perfusion and Metabolic Activity in HFpEF

Conditions

Heart Failure With Preserved Ejection Fraction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Matching Perfusion and Metabolic Activity in HFpEF

Quick Facts

Study Start:2021-10-11

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04913805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. NYHA Class II-III symptoms 2. Left ventricular ejection fraction \>= 50% 3. Stable medical therapy for at least 1 month 4. Prior or current evidence for elevated filling pressures as follows:	1. Age \<18 years old 2. Pregnancy: 3. Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted 4. Uncontrolled atrial fibrillation, as defined by a resting heart rate \> 100 beats per minute at the time of the baseline assessment 5. Hemoglobin \< 10 g/dL 6. Subject inability/unwillingness to exercise 7. Moderate or greater left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), mild or greater mitral stenosis, severe right-sided valvular disease 8. Known hypertrophic, infiltrative, or inflammatory cardiomyopathy 9. Clinically significant pericardial disease, as per investigator judgment 10. Current angina due to clinically significant epicardial coronary disease, as per investigator judgment 11. Acute coronary syndrome or coronary intervention within the past 2 months 12. Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension) 13. Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease meeting Stage III or greater GOLD criteria (FEV1\<50%), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea, desaturation to \<90% on the baseline maximal effort cardiopulmonary exercise test 14. Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test) 15. Left ventricular ejection fraction \< 45% on a prior echocardiogram or cardiac MRI 16. Significant liver disease impacting synthetic function or volume control (ALT/AST \> 3x ULN, Albumin \< 3.0 g/dL) 17. eGFR \< 30 mL/min/1.73m\^2 18. Methemoglobin \> 5% 19. Serum potassium \> 5.0 mEq/L 20. Severe right ventricular dysfunction 21. Baseline resting seated systolic blood pressure \> 180 mmHg or \< 100 mmHg 22. Orthostatic blood pressure response to the transition from supine to standing (\>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing) 23. Active participation in another study that utilizes an investigational agent (observational studies/registries allowed) 24. Any condition that, in the opinion of the investigator, will interfere with the performance and completion of the study. 25. Contraindications to MRI

Inclusion Criteria

Exclusion Criteria

1. NYHA Class II-III symptoms
2. Left ventricular ejection fraction \>= 50%
3. Stable medical therapy for at least 1 month
4. Prior or current evidence for elevated filling pressures as follows:

1. Age \<18 years old
2. Pregnancy:
3. Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted
4. Uncontrolled atrial fibrillation, as defined by a resting heart rate \> 100 beats per minute at the time of the baseline assessment
5. Hemoglobin \< 10 g/dL
6. Subject inability/unwillingness to exercise
7. Moderate or greater left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), mild or greater mitral stenosis, severe right-sided valvular disease
8. Known hypertrophic, infiltrative, or inflammatory cardiomyopathy
9. Clinically significant pericardial disease, as per investigator judgment
10. Current angina due to clinically significant epicardial coronary disease, as per investigator judgment
11. Acute coronary syndrome or coronary intervention within the past 2 months
12. Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension)
13. Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease meeting Stage III or greater GOLD criteria (FEV1\<50%), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea, desaturation to \<90% on the baseline maximal effort cardiopulmonary exercise test
14. Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test)
15. Left ventricular ejection fraction \< 45% on a prior echocardiogram or cardiac MRI
16. Significant liver disease impacting synthetic function or volume control (ALT/AST \> 3x ULN, Albumin \< 3.0 g/dL)
17. eGFR \< 30 mL/min/1.73m\^2
18. Methemoglobin \> 5%
19. Serum potassium \> 5.0 mEq/L
20. Severe right ventricular dysfunction
21. Baseline resting seated systolic blood pressure \> 180 mmHg or \< 100 mmHg
22. Orthostatic blood pressure response to the transition from supine to standing (\>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing)
23. Active participation in another study that utilizes an investigational agent (observational studies/registries allowed)
24. Any condition that, in the opinion of the investigator, will interfere with the performance and completion of the study.
25. Contraindications to MRI

Contacts and Locations

Study Contact

Melissa Fernand, MPH

CONTACT

2672536141

fernand@pennmedicine.upenn.edu

Cassandra Demastus, NP

CONTACT

4432719022

Cassandra.Demastus@Pennmedicine.upenn.edu

Principal Investigator

Payman Zamani, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Payman Zamani, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-11

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2021-10-11

Study Completion Date2026-01-31

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure With Preserved Ejection Fraction