Investigating exercise difficulties in heart failure patients
Exercise Intolerance in Heart Failure: the Role of Altered Cardiac and Skeletal Muscle Energetics
This study is trying to understand why people with heart failure have trouble exercising by looking at the energy levels in their heart and leg muscles.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03775577 on ClinicalTrials.gov |
What this trial studies
This research focuses on understanding the metabolic abnormalities in cardiac and skeletal muscles of patients with heart failure with preserved ejection fraction (HFpEF) that contribute to exercise intolerance. The study will measure metabolites in the heart and leg muscles using magnetic resonance techniques to assess levels of high-energy phosphates and lipids. By identifying these metabolic issues, the study aims to shed light on the challenges faced by patients in performing daily activities and exercising.
Who should consider this trial
Good fit: Ideal candidates include adults over 21 years old with a clinical diagnosis of heart failure and current NYHA Class II-III symptoms.
Not a fit: Patients with contraindications to MRI or significant valvular abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with heart failure, enhancing their ability to exercise and perform daily activities.
How similar studies have performed: Other studies have explored metabolic abnormalities in heart failure, but this specific approach using magnetic resonance techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Robert G Weiss, MD — Johns Hopkins University
- Study coordinator: Matthew Kauffman
- Email: mkauffm7@jhmi.edu
- Phone: 443-287-3475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.