Sarcopenia Magnetic Resonance Imaging Evaluation (SUSIE) (SUSIE)

February 9, 2026 updated by: Wilson Tang, The Cleveland Clinic

Sarcopenia Characterization Using Magnetic Resonance Fingerprinting and Phosphorous Magnetic Resonance Spectroscopic Imaging Evaluation (SUSIE)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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/frail 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Timothy A Engelman, LPN
  • Phone Number: 216-636-6153
  • Email: engelmt@ccf.org

Study Contact Backup

  • Name: Wilcox D Wilcox, BA
  • Phone Number: 216-636-6153
  • Email: kirsopj@ccf.org

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Brendan Eck, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Heart Failure and Healthy volunteers

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anticipated Results
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cleveland Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: W. H. Wilson Tang, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-124

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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