CV Imaging of Metabolic Interventions

NCT05650307 | Recruiting

• 1 other identifier: 22-695
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Bariatric Surgery Candidate; Heart Failure; Cardiovascular Diseases

Keywords

MRI; Exercise; Weight loss; Cardiac Rehabilitation; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Study Arms (3)

Healthy controls

Diagnostic Test: MRI

Bariatric Surgery patients

Diagnostic Test: MRI

Cardiac rehabilitation patients

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_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.

Bariatric Surgery patients; Cardiac rehabilitation patients; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cardiovascular Innovation Research Center

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood draw

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Heart Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

CIRC Program Coordinator

CONTACT

216 636-5373; circ@ccf.org

CIRC Study Coordinator

CONTACT

chens7@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Innovation Research Center

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 14, 2022
• Study Start: September 9, 2022
• Primary Completion (Estimated): September 9, 2027
• Study Completion (Estimated): September 9, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)