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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03775577
Other study ID # IRB00129787
Secondary ID R01HL061912
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date March 2025

Study information

Verified date August 2023
Source Johns Hopkins University
Contact Matthew Kauffman
Phone 443-287-3475
Email mkauffm7@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators are studying whether metabolic abnormalities in cardiac and skeletal muscle in patients with heart failure with preserved ejection fraction (HFpEF) are associated with debilitating exercise intolerance.


Description:

This research is being done to better understand why patients with heart failure have difficulty exercising and performing some activities of daily living. Heart muscle and skeletal muscle (in the legs and arms) depend on normal metabolism (the conversion of foods to chemical fuel) to function properly. Investigators will measure metabolites in the heart and leg muscles, including the levels of high energy phosphates and lipids (fats) using magnetic resonance (MR) techniques. High-energy phosphates serve as a source of energy, which is used by the heart and skeletal muscle for contraction. Magnetic resonance uses magnetic fields to measure the levels of these substances.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Patients of either gender who are greater than 21 years of age (no upper age limit), - Permission of patient's clinical attending physician, - Previous clinical diagnosis of HF with current New York Heart Association (NYHA) Class II-III symptoms for at least 1 month, - Left ventricular ejection fraction (EF) >50% by echocardiography, MRI, CT or x-ray or nuclear ventriculography within prior 12 months, - Stable medical therapy for at least 30 days (no addition or removal or major (>100%) dose change of Renin-Angiotensin-Aldosterone System (RAAS) antagonists, beta-blockers, or calcium channel blockers for hypertension). Exclusion Criteria: - Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent, - Contraindications to MRI such as implanted metallic objects (pre-existing cardiac pacemakers, cerebral clips) or indwelling metallic projectiles, - Significant valvular abnormalities, - Pregnant women (women of childbearing potential will undergo blood or urine pregnancy testing), - History of clinical CAD or significant epicardial coronary disease (>50% stenosis) in major coronary artery by x-ray or CT angiography unless (a) the patient underwent prior successful revascularization with percutaneous coronary angioplasty within the prior three years and (b) there are no residual lesions of >50% on the most recent coronary angiographic study. - History of infiltrative cardiomyopathy or constrictive pericarditis, - Cor pulmonale, - Significant pulmonary disease, - Estimated glomerular filtration rate (eGFR) <20ml/min, - Any condition other than HF which could limit the ability to perform a 6MW or cardiopulmonary exercise test (CPET) test (e.g., critical peripheral vascular disease, significant orthopedic or neurological conditions), - Any diseases other than HF which are likely to significantly alter the patient's global perception of status or quality of life over a period of 6 months. - Significant peripheral vascular disease

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skeletal muscle mitochondrial function Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS) Baseline
Primary Skeletal muscle energetic decline during exercise Creatine phosphate rate of decline (umol/g/min) during plantar flexion exercise measured by 31P MRS Baseline
Primary Cardiac muscle energetics Cardiac muscle phosphocreatine (PCr)/ adenosine triphosphate (ATP) and creatine kinase(CK) flux (umol/g/s) measured by 31P MRS Baseline
Secondary Six minute walk test Six minute walk distance (m) Six months
Secondary Cardiopulmonary exercise testing (CPET) Peak whole-body oxygen consumption rate during exercise Six months
Secondary Clinical heart failure outcome as assessed by number of hospitalizations Two years
Secondary Clinical heart failure outcome as assessed by time to cardiovascular death Two years
Secondary Clinical heart failure outcome as assessed by overall mortality Two years
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