Sarcopenia Magnetic Resonance Imaging Evaluation (SUSIE)

NCT04869813 | Recruiting

• 1 other identifier: 21-124
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Heart failure patients

Inclusion criteria: * Age \> or = 40 yrs * Stable chronic heart failure * Systolic dysfunction determined by cardiac MRI with left ventricle ejection fraction 40% or less Exclusion criteria: • Advanced liver disease, advanced cancer, advanced chronic obstructive pulmonary disease Contraindications to MRI such as: * 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)

Healthy volunteers (Controls)

Inclusion criteria: * Age \> or = 40 yrs * No diagnosed heart failure or sarcopenia Exclusion criteria • Advanced liver disease, advanced cancer, advanced chronic obstructive pulmonary disease Contraindications to MRI such as: * 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)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Heart Failure and Healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• W. H. Wilson Tang, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy A Engelman, LPN

CONTACT

216-636-6153; engelmt@ccf.org

Wilcox D Wilcox, BA

CONTACT

216-636-6153; kirsopj@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiovascular and Metabolic Sciences

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: April 9, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)