| NCT ID | NCT03775577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Heart Failure With Normal Ejection Fraction |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2017-04-01 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2017-04-01 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Robert G Weiss, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT03775577 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Heart Failure With Normal Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03775577 currently recruiting?
Yes, NCT03775577 is actively recruiting participants. Contact the research team at mkauffm7@jhmi.edu for enrollment information.
Where is the NCT03775577 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03775577 clinical trial?
NCT03775577 is sponsored by Johns Hopkins University. The principal investigator is Robert G Weiss, MD at Johns Hopkins University. The trial plans to enroll 130 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.