Evaluating muscle health in heart failure patients using MRI techniques
Sarcopenia Characterization Using Magnetic Resonance Fingerprinting and Phosphorous Magnetic Resonance Spectroscopic Imaging Evaluation (SUSIE)
This study is testing new MRI techniques to see if they can help doctors better understand and spot muscle problems in heart failure patients, especially those with muscle loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04869813 on ClinicalTrials.gov |
What this trial studies
This research investigates the use of Magnetic Resonance Fingerprinting and Phosphorus-31 MR Spectroscopy imaging to characterize skeletal muscle in heart failure patients, particularly focusing on those with sarcopenia. The study aims to provide a non-invasive assessment of muscle mass and function by analyzing T1, T2 relaxation times, and phosphocreatine recovery rates. By comparing heart failure patients with and without sarcopenia, the study seeks to establish more effective diagnostic tools that can identify muscle deterioration earlier than current methods. This could lead to improved management strategies for heart failure patients.
Who should consider this trial
Good fit: Ideal candidates include heart failure patients aged 40 and older with systolic dysfunction and healthy volunteers without heart failure or sarcopenia.
Not a fit: Patients with advanced liver disease, cancer, or chronic obstructive pulmonary disease, as well as those with contraindications to MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel, non-invasive method for early detection and management of sarcopenia in heart failure patients.
How similar studies have performed: While MRI has been used in other contexts, this specific application of MR Fingerprinting and P-MRS for sarcopenia characterization in heart failure is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Heart failure patients * Age ≥40 yrs * Stable chronic heart failure * Systolic dysfunction determined by cardiac MRI with left ventricle ejection fraction 40% or less * Healthy Volunteers * Age ≥40 yrs * No diagnosed heart failure or sarcopenia Exclusion Criteria: * Heart failure patients • Advanced liver disease, advanced cancer, advanced chronic obstructive pulmonary disease * Healthy volunteers (controls) * Advanced liver disease, advanced cancer, advanced chronic obstructive pulmonary disease * Contraindications to MRI Contraindications to MRI * Heart pacemaker/defibrillator * Electronic/implanted stimulators or devices, including deep brain stimulator, vagus nerve stimulator, bladder stimulator, spine stimulator, neurostimulators; implanted electrodes or wires * Cochlear implant or other ear implants * Implanted drug pumps (insulin, narcotic/pain medications, drugs to treat spasticity) * Programmable shunt * Aneurysm clips and coils * Stents * Filters (for example, blood clot filters) * Metal fragment in body or eye (eg, BBs, bullets, shrapnel, metal pieces or shavings)
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: W. H. Wilson Tang, MD — The Cleveland Clinic
- Study coordinator: Timothy A Engelman, LPN
- Email: engelmt@ccf.org
- Phone: 216-636-6153
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.