SarcopeniaSUSIENCT04869813
Sarcopenia Magnetic Resonance Imaging Evaluation (SUSIE)
An observational study of Sarcopenia, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sarcopenia
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart Failure and Healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start9 Apr 2021
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Tang, The Cleveland Clinic
- Investigators
- W. H. Wilson Tang, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869813
- Sponsor's protocol ID
- 21-124
- Acronym
- SUSIE
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2021
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia Characterization Using Magnetic Resonance Fingerprinting and Phosphorous Magnetic Resonance Spectroscopic Imaging Evaluation (SUSIE)
- ClinicalTrials.gov ID
- NCT04869813
- Acronym / sponsor ID
- SUSIE / 21-124
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Failure and Healthy volunteers
Key inclusion criteria (7 listed)
- Heart failure patients
- Healthy Volunteers
Key exclusion criteria (14 listed)
- Heart failure patients
- Healthy volunteers (controls)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related trials for Sarcopenia
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
W. H. Wilson Tang, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anticipated Results (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.