Exercise Intolerance in Heart Failure

Launched by JOHNS HOPKINS UNIVERSITY · Dec 11, 2018

Keywords

ClinConnect Summary

This clinical trial is looking into why some people with heart failure feel very tired and have trouble exercising, even though their heart function looks normal. Researchers want to find out if there are problems in the muscles of these patients that could be causing this exercise intolerance. They are currently recruiting participants who are over 21 years old and have been diagnosed with heart failure, specifically those showing moderate symptoms for at least a month. To qualify, participants should have a heart function score (known as ejection fraction) of more than 50% and have been on stable heart medication for the past month.

If you decide to participate, you can expect to undergo tests that will help researchers understand how your heart and muscles are functioning during exercise. It’s important to note that certain conditions, such as severe heart valve problems or significant lung diseases, may prevent you from joining the study. This trial aims to improve understanding of heart failure with preserved ejection fraction and potentially lead to better treatments for those struggling with exercise.

Gender

ALL

Eligibility 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