[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04869813":3,"trial-entities:NCT04869813":78,"trial-summary:NCT04869813":82},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":34,"minimum_age":35,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":36,"std_ages":58,"locations":61,"central_contacts":71,"overall_officials":72,"references":76,"see_also_links":77},"NCT04869813","21-124","Sarcopenia Magnetic Resonance Imaging Evaluation (SUSIE)","Sarcopenia Characterization Using Magnetic Resonance Fingerprinting and Phosphorous Magnetic Resonance Spectroscopic Imaging Evaluation (SUSIE)","ENROLLING_BY_INVITATION","2026-12-31","2026-06","2026-06-25","2021-04-09","The Cleveland Clinic","OTHER",false,"The goal of the proposed research is to investigate Magnetic Resonance (MR) Fingerprinting and P-MRS (Phosphorus-31 MR Spectroscopy) imaging for characterization of skeletal muscle in heart failure patients with sarcopenia. Heart failure patients with and without sarcopenia will be scanned using MR Fingerprinting and an existing Post-exercise phosphocreatine (PCr) recovery MR imaging protocol to obtain characteristic profiles of quantitative T1, T2, and PCr recovery rate.","Sarcopenia is a common comorbidity and predictor of mortality in heart failure that is characterized by a loss of muscle mass and functional strength. Sarcopenia, in heart failure and other chronic diseases, has been consistently predictive of poor outcomes. However, current tools to identify the presence of sarcopenia, such as functional tests and questionnaires are indirect, non-specific, and not effective until patients have reached an overtly cachectic state and significant muscle deterioration has already occurred. MRI can serve an important, noninvasive role in the assessment and management of sarcopenia by providing insight as to tissue microstructure and mitochondrial function. For example, MRI has shown significant changes in T2 relaxation time, diffusion fractional anisotropy, and lipid content in skeletal muscle of pre-frail\u002Ffrail patients as compared to healthy volunteers. Post-exercise phosphocreatine (PCr) recovery, evaluated using phosphorus-31 (P) MR spectroscopy Imaging(P-MRSI), has shown impairment of mitochondrial function in pre-frail elderly as compared to active elderly. MR fingerprinting (MRF) is a promising tool for tissue characterization via rapid, robust quantification of T1 and T2 relaxation and has been shown to be accurate and reproducible across sites. Despite applications in neuroimaging and cardiac imaging, MRF has had limited use in musculoskeletal imaging and has not been investigated for use in characterizing sarcopenia. Similarly, P-MRS imaging has not been employed for evaluation of sarcopenia in heart failure patients, a population which may have a unique etiology from other sarcopenia phenotypes. Characterization of sarcopenia may support a range of rapidly developing treatment options in this population. While evidence suggests exercise therapy can improve frailty status, for instance in 39% of patients at 12 month follow-up, it is not yet well-understood which patients will respond to treatment. With a range of treatment options such as nutritional supplementation, hormone therapy, and cardiovascular drugs, MRF and P-MRSI could serve as powerful noninvasive tools to provide a personalized approach for sarcopenic phenotypes, match them to appropriate therapy, and monitor therapeutic response.",[19],"Sarcopenia",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},70,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Anticipated Results","This proposal is expected to produce information as to the change in T1, T2, muscle area, fat fraction, and PCr recovery rate values for heart failure patients with sarcopenia as compared to non-sarcopenic volunteers. Future work will expand upon this study to evaluate to progression of sarcopenia, and evaluate the prognostic value of imaging biomarkers (T1, T2, muscle area, fat fraction, PCr recovery) in predicting heart failure and sarcopenic related outcomes.","3 years",[],"ALL","40 Years",{"inclusion":37,"exclusion":44,"raw_text":57},[38,39,40,41,42,39,43],"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","No diagnosed heart failure or sarcopenia",[38,45,46,47,48,49,50,51,52,53,54,55,56],"Healthy volunteers (controls)","Advanced liver disease, advanced cancer, advanced chronic obstructive pulmonary disease","Contraindications to MRI Contraindications to MRI","Heart pacemaker\u002Fdefibrillator","Electronic\u002Fimplanted 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\u002Fpain 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)","Inclusion Criteria:\n\n* Heart failure patients\n\n  * Age ≥40 yrs\n  * Stable chronic heart failure\n  * Systolic dysfunction determined by cardiac MRI with left ventricle ejection fraction 40% or less\n* Healthy Volunteers\n\n  * Age ≥40 yrs\n  * No diagnosed heart failure or sarcopenia\n\nExclusion Criteria:\n\n* Heart failure patients\n\n  • Advanced liver disease, advanced cancer, advanced chronic obstructive pulmonary disease\n* Healthy volunteers (controls)\n\n  * Advanced liver disease, advanced cancer, advanced chronic obstructive pulmonary disease\n  * Contraindications to MRI Contraindications to MRI\n  * Heart pacemaker\u002Fdefibrillator\n  * Electronic\u002Fimplanted stimulators or devices, including deep brain stimulator, vagus nerve stimulator, bladder stimulator, spine stimulator, neurostimulators; implanted electrodes or wires\n  * Cochlear implant or other ear implants\n  * Implanted drug pumps (insulin, narcotic\u002Fpain medications, drugs to treat spasticity)\n  * Programmable shunt\n  * Aneurysm clips and coils\n  * Stents\n  * Filters (for example, blood clot filters)\n  * Metal fragment in body or eye (eg, BBs, bullets, shrapnel, metal pieces or shavings)",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"city":64,"state":65,"zip":66,"country":67,"geoPoint":68},"Cleveland Clinic","Cleveland","Ohio","44195","United States",{"lat":69,"lon":70},41.4995,-81.69541,[],[73],{"name":74,"affiliation":13,"role":75},"W. H. Wilson Tang, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":79,"biomarkers":81},[80,19],"Heart Failure",[],{"nct_id":4,"found":83,"summary":84,"prompt_version":94},true,{"design":85,"status":86,"heading":87,"summary":88,"follow_up":89,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"This is an observational study involving up to 70 participants, including heart failure patients and healthy volunteers.","completed","Sarcopenia MRI Evaluation (SUSIE) in Heart Failure Patients","This study, called SUSIE, is looking at new ways to detect sarcopenia (a condition involving loss of muscle mass and strength) in people with heart failure. Researchers are using special MRI techniques, called MR Fingerprinting and P-MRS (Phosphorus-31 MR Spectroscopy), to get a clearer picture of muscle health. They want to see if these MRI methods can better identify sarcopenia in heart failure patients, compared to current methods. You might be able to join if you are at least 40 years old and have stable chronic heart failure with reduced pumping ability of your heart, or if you are a healthy volunteer without heart failure or sarcopenia. The study aims to gather results over 3 years.","The anticipated results will be measured at 3 years.",116,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]