Bariatric Surgery CandidateCIRCMetaNCT05650307
CV Imaging of Metabolic Interventions
An observational study of Bariatric Surgery Candidate and Heart Failure, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Cardiovascular disease is the leading cause of death worldwide. It is becoming clearer that heart failure (HF) is closely associated with body's metabolism. Even before the heart becomes weaker, it responds to the stresses by changing the fuels it burns, which results in a reduction in the heart's metabolic efficiency… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Heart Failure, Cardiovascular Diseases
- What is being tested?
- MRI
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 9 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 150 subjects (50 for each study arm and 50 healthy controls) will be recruited from the Cleveland Clinic who have been diagnosed with cardiovascular disease and are eligible for the study.
Who may be able to join
- Age > 18 years of age
- Provision of written informed consent
- For bariatric surgery group, obesity (BMI>/=30 kg/m2) and non-obese (BMI <30 kg/m2; for control group)
- For cardiac rehabilitation group, symptomatic cardiovascular disease for patients and no signs of cardiovascular disease for healthy controls
Who cannot join
- Vulnerable populations will be excluded from this study including Prisoners
- Contraindication to CMR imaging to be determined by standard MRI protocols
- Decisionally impaired (e.g. dementia or cognitive disability)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
CIRC Study Coordinator contact
United States1 site, 1 recruiting
- Recruiting
Cardiovascular Innovation Research Center
Cleveland, Ohio, 44195
CIRC Study Coordinator, 216-445-8561, chens7@ccf.org
Christopher Nguyen, PhD
About this study
Official title: Cardiovascular Imaging to Assess Responses to Metabolic Interventions
Cardiovascular disease is the leading cause of death worldwide. It is becoming clearer that heart failure (HF) is closely associated with body's metabolism. Even before the heart becomes weaker, it responds to the stresses by changing the fuels it burns, which results in a reduction in the heart's metabolic efficiency that worsens the heart's condition. Since the heart burns so much fuel and consumes fats and carbohydrates along with other available substrates, any changes in its metabolic efficiency could impact metabolism throughout the body. Specifically, HF is characterized by limited flexibility in substrate utilization leading to an overall energetic deficit. Such energetic deficit is associated with progressive remodeling and alter cardiac hemodynamics. For example, obesity is a widely known risk factor for cardiovascular disease likely lie in how the heart handles energy (substrate utilization and energetics). One commonly recommended treatment for cardiovascular disease, especially coronary artery disease (CAD) or congestive heart failure (CHF), is cardiac rehabilitation. Cardiac rehabilitation for symptomatic cardiovascular disease has been shown to promote a healthy lifestyle, improve physical health and reduce cardiovascular death iii with an apparent dose-dependent response. Participation results in a reduced risk of hospitalization and revascularization procedures, and improved functional status in randomized controlled trials. Thus, cardiac rehabilitation is recommended for individuals with symptomatic CAD or CHF by the American College of Cardiology and American Heart Association. In addition, exercise training in preclinical animal models mirroring the exercise component of cardiac rehabilitation routines have shown increased myocardial regeneration and cardioprotective molecular effects ameliorating adverse myocardial remodeling. Despite these benefits, there is vast heterogeneity in the efficiency of cardiac rehabilitation on the individual level with large variances in improved exercise capacity and cardiac function recovery. Personalization of cardiac rehabilitation necessitates a non-invasive approach to monitor the direct beneficial effects on the heart and more ideally, predict efficacy at baseline. Taken together, understanding how metabolic interventions including bariatric surgery and cardiac rehabilitation change myocardial structure and function is critical for the prevention, diagnosis and prognosis for patients with cardiovascular diseases.
Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Our team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In collaboration with cardiologists at Cleveland Clinic, the investigators aim to study how myocardial microstructure revealed by cardiac MRI changes cardiovascular disease patient population before and after metabolic interventions.
Read the detailed description
The primary clinical objective of the clinical study is to (1) determine cardiac microstructural phenotypes by cardiac MRI in patients before and after cardiac rehabilitation, or bariatric surgery, and their relationship to cardiac structure/function.
Aim 1: How does the heart's microstructure change before and after cardiac rehabilitation or bariatric surgery? Is this linked to other prevalent macro structure and functional abnormalities and how they change after each metabolic intervention (e.g., cardiac mass or strain)?
Our hypothesis is that characteristic alterations in myocardial microstructure reflected in non-contrast MRI are prevalent in symptomatic cardiovascular disease before and after the respective interventions and may help early detection of cardiovascular disease.
The investigators have chosen a prospective longitudinal cohort design to test the hypothesis that cardiac structure and function change significantly following cardiac rehabilitation or bariatric surgery.
There are TWO arms of the study:
The study protocol for those undergoing cardiac rehabilitation will involve:
- Consent
- MRI at the beginning of 12 weeks of cardiac rehabilitation at Cleveland Clinic. Subjects may opt to complete an MRI of the leg in addition to the cardiac MRI. Patients who opt for both have the option to complete the scans at separate visits.
- Subjects will be scheduled for a 6 week scan if available; however, participation will be optional
- MRI after 12 weeks of cardiac rehabilitation at the Cardiovascular Disease Prevention Center at Cleveland Clinic. If subjects opted to complete both a cardiac scan and a leg scan, the patients have the option to complete these at separate visits.
The study protocol for those who participate in bariatric surgery study:
- Consent
- MRI prior to the bariatric surgery.
- MRI within 12 months of surgery.
Optionally, if the subjects agree, the blood samples will be collected:
- Give blood sample for research purpose only. The blood draw is used to correlate the clinical blood biomarkers to the cardiac MRI data to help us better understand and validate the clinical utility of the novel cardiac MRI techniques. The blood draws should approximately take 20 minutes. The blood draw will take place in the doctor's office or at Mellen center private preparation by a registered nurse or approved technician. The blood will be stored at Lerner freezers until needed for analysis and being analyzed for biomarkers only for this study. It will not be used for future research in the Cleveland Clinic. Only members of the research team will have access to the samples.
The study protocol for healthy volunteers will involve:
- Consent
- One MRI Scan
- Being tested
- MRI
- Keywords
- MRI, Exercise, Weight loss, Cardiac Rehabilitation, Bariatric Surgery
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
The magnetic field exposure for MRI in this study is similar to standard clinical MR procedures. The powers of all radio frequency fields in this study are at or under FDA guidelines. The CMR techniques performed here have been used in the literature and in our own clinical cardiac MRI service extensively for several years and have an excellent safety profile in our institution.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: Diagnostic Test: MRI | |
| Bariatric Surgery patients | Not described Receives: Diagnostic Test: MRI | |
| Cardiac rehabilitation patients | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Microstructure from baseline and 6-12months
The primary clinical objective of the clinical study is to (1) determine cardiac microstructural phenotypes by cardiac MRI in patients before and after cardiac rehabilitation, or bariatric surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start9 Sep 2022
- Primary completion9 Sep 2027 (estimated)
- Study completion9 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Nguyen, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650307
- Sponsor's protocol ID
- 22-695
- Acronym
- CIRCMeta
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Imaging to Assess Responses to Metabolic Interventions
- ClinicalTrials.gov ID
- NCT05650307
- Acronym / sponsor ID
- CIRCMeta / 22-695
- Keywords
- MRI, Exercise, Weight loss, Cardiac Rehabilitation, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 9 Sep 2027 (estimated)
- Study completion
- 9 Sep 2027 (estimated)
- First posted
- 14 Dec 2022 (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.
Cardiovascular disease is the leading cause of death worldwide. It is becoming clearer that heart failure (HF) is closely associated with body's metabolism. Even before the heart becomes weaker, it responds to the stresses by changing the fuels it burns, which results in a reduction in the heart's metabolic efficiency that worsens the heart's condition. Since the heart burns so much fuel and consumes fats and carbohydrates along with other available substrates, any changes in its metabolic efficiency could impact metabolism throughout the body. Specifically, HF is characterized by limited flexibility in substrate utilization leading to an overall energetic deficit. Such energetic deficit is associated with progressive remodeling and alter cardiac hemodynamics. For example, obesity is a widely known risk factor for cardiovascular disease likely lie in how the heart handles energy (substrate utilization and energetics). One commonly recommended treatment for cardiovascular disease, especially coronary artery disease (CAD) or congestive heart failure (CHF), is cardiac rehabilitation. Cardiac rehabilitation for symptomatic cardiovascular disease has been shown to promote a healthy lifestyle, improve physical health and reduce cardiovascular death iii with an apparent dose-dependent response. Participation results in a reduced risk of hospitalization and revascularization procedures, and improved functional status in randomized controlled trials. Thus, cardiac rehabilitation is recommended for individuals with symptomatic CAD or CHF by the American College of Cardiology and American Heart Association. In addition, exercise training in preclinical animal models mirroring the exercise component of cardiac rehabilitation routines have shown increased myocardial regeneration and cardioprotective molecular effects ameliorating adverse myocardial remodeling. Despite these benefits, there is vast heterogeneity in the efficiency of cardiac rehabilitation on the individual level with large variances in improved exercise capacity and cardiac function recovery. Personalization of cardiac rehabilitation necessitates a non-invasive approach to monitor the direct beneficial effects on the heart and more ideally, predict efficacy at baseline. Taken together, understanding how metabolic interventions including bariatric surgery and cardiac rehabilitation change myocardial structure and function is critical for the prevention, diagnosis and prognosis for patients with cardiovascular diseases.
Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Our team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In collaboration with cardiologists at Cleveland Clinic, the investigators aim to study how myocardial microstructure revealed by cardiac MRI changes cardiovascular disease patient population before and after metabolic interventions.
Detailed description
The primary clinical objective of the clinical study is to (1) determine cardiac microstructural phenotypes by cardiac MRI in patients before and after cardiac rehabilitation, or bariatric surgery, and their relationship to cardiac structure/function.
Aim 1: How does the heart's microstructure change before and after cardiac rehabilitation or bariatric surgery? Is this linked to other prevalent macro structure and functional abnormalities and how they change after each metabolic intervention (e.g., cardiac mass or strain)?
Our hypothesis is that characteristic alterations in myocardial microstructure reflected in non-contrast MRI are prevalent in symptomatic cardiovascular disease before and after the respective interventions and may help early detection of cardiovascular disease.
The investigators have chosen a prospective longitudinal cohort design to test the hypothesis that cardiac structure and function change significantly following cardiac rehabilitation or bariatric surgery.
There are TWO arms of the study:
The study protocol for those undergoing cardiac rehabilitation will involve:
- Consent
- MRI at the beginning of 12 weeks of cardiac rehabilitation at Cleveland Clinic. Subjects may opt to complete an MRI of the leg in addition to the cardiac MRI. Patients who opt for both have the option to complete the scans at separate visits.
- Subjects will be scheduled for a 6 week scan if available; however, participation will be optional
- MRI after 12 weeks of cardiac rehabilitation at the Cardiovascular Disease Prevention Center at Cleveland Clinic. If subjects opted to complete both a cardiac scan and a leg scan, the patients have the option to complete these at separate visits.
The study protocol for those who participate in bariatric surgery study:
- Consent
- MRI prior to the bariatric surgery.
- MRI within 12 months of surgery.
Optionally, if the subjects agree, the blood samples will be collected:
- Give blood sample for research purpose only. The blood draw is used to correlate the clinical blood biomarkers to the cardiac MRI data to help us better understand and validate the clinical utility of the novel cardiac MRI techniques. The blood draws should approximately take 20 minutes. The blood draw will take place in the doctor's office or at Mellen center private preparation by a registered nurse or approved technician. The blood will be stored at Lerner freezers until needed for analysis and being analyzed for biomarkers only for this study. It will not be used for future research in the Cleveland Clinic. Only members of the research team will have access to the samples.
The study protocol for healthy volunteers will involve:
- Consent
- One MRI Scan
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: MRI |
| Bariatric Surgery patients | – | Diagnostic Test: MRI |
| Cardiac rehabilitation patients | – | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 150 subjects (50 for each study arm and 50 healthy controls) will be recruited from the Cleveland Clinic who have been diagnosed with cardiovascular disease and are eligible for the study.
Key inclusion criteria (4 listed)
- Age > 18 years of age
- Provision of written informed consent
- For bariatric surgery group, obesity (BMI>/=30 kg/m2) and non-obese (BMI <30 kg/m2; for control group)
- For cardiac rehabilitation group, symptomatic cardiovascular disease for patients and no signs of cardiovascular disease for healthy controls
Key exclusion criteria (3 listed)
- Vulnerable populations will be excluded from this study including Prisoners
- Contraindication to CMR imaging to be determined by standard MRI protocols
- Decisionally impaired (e.g. dementia or cognitive disability)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIThe magnetic field exposure for MRI in this study is similar to standard clinical MR procedures. The powers of all radio frequency fields in this study are at or under FDA guidelines. The CMR techniques performed here have been used in the literature and in our own clinical cardiac MRI service extensively for several years and have an excellent safety profile in our institution. | Diagnostic test | Bariatric Surgery patients, Cardiac rehabilitation patients, Healthy controls |
Primary outcome
Change of Microstructure from baseline and 6-12months
Time frame: 5 years
The primary clinical objective of the clinical study is to (1) determine cardiac microstructural phenotypes by cardiac MRI in patients before and after cardiac rehabilitation, or bariatric surgery
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 8 May 2026.
- Individual participant dataSharing planned: No
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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.
CIRC Study Coordinator contact
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 Bariatric Surgery Candidate and Heart Failure, 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 May 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?
Contact CIRC Program Coordinator (216 636-5373, circ@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Microstructure from baseline and 6-12months (time frame: 5 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 8 May 2026.