Changes in Intramyocardial Fat Assessed by Cardiac CT Before and After Bariatric Surgery and Their Relationship With Cardiac Diastolic Function

NCT07565610 | Not Yet Recruiting

• 1 other identifier: SZMC-0044-26
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn if weight loss surgery can lower fat inside the heart muscle and improve how the heart relaxes in adults with obesity. The main questions it aims to answer are: Does fat inside the heart muscle decrease after weight loss surgery? Does heart relaxation (diastolic function) improve after surgery? Are changes in heart fat linked to changes in weight, body fat, and blood markers? Participants who are already planning to have weight loss surgery will take part in this study. Participants will: Have a heart CT scan to measure fat in the heart muscle before surgery and about 6 months after surgery Have an ultrasound of the heart (echocardiogram) to check how the heart fills and relaxes Have body composition testing to measure fat and muscle Have blood tests, including routine tests and additional markers related to heart function and metabolism Researchers will compare each participant's results before and after surgery to see if heart fat decreases and if heart function and blood markers improve.

Conditions

Obesity; Diastolic Dysfunction; Heart Failure With Preserved Ejection Fraction (HFPEF)

Outcome Measures

Primary Outcomes (1)

• Change in intramyocardial fat content assessed by cardiac CT

  Change in intramyocardial fat quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery

  Baseline to 6 months

Secondary Outcomes (6)

• Correlation coefficient between change in intramyocardial fat and change in diastolic function grade

  Baseline to 6 months

• Change in diastolic function grade

  Baseline to 6 months

• Change in body composition

  Baseline to 6 months

• Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)

  Baseline to 6 months

• Change in pericardial fat volume

  Baseline to 6 months

Study Arms (1)

Adults Undergoing Bariatric Surgery

Eligibility Criteria

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

Study Population

Adults with obesity who are scheduled to undergo bariatric surgery for standard clinical care at a tertiary medical center. Participants will be recruited during their preoperative evaluation and will undergo baseline and follow-up assessments, including cardiac imaging and clinical measurements, as part of the study.

You may qualify if:

• Adults aged 18 years or older
• Scheduled to undergo bariatric surgery for standard clinical indications
• Left ventricular ejection fraction (LVEF) ≥50%
• Able to undergo cardiac computed tomography (CT)

You may not qualify if:

• Left ventricular ejection fraction (LVEF) \<50%
• Known cardiomyopathies, including sarcoidosis, amyloidosis, or myocarditis
• Significant valvular heart disease
• Contraindication to cardiac CT (e.g., severe renal dysfunction, contrast allergy)
• Presence of intracardiac or cardiac-related foreign material that may interfere with imaging (e.g., prosthetic valves, pacemakers, prior transcatheter devices)

Sponsors & Collaborators

• Itshak Amsalem: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Itshak Amsalem, MD

CONTACT

+972508229454; itshak1a@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04