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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Diastolic Dysfunction; Heart Failure With Preserved Ejection Fraction (HFPEF)

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Itshak Amsalem, MD; Phone Number: +972508229454; Email: itshak1a@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adults Undergoing Bariatric Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation coefficient between change in intramyocardial fat and change in diastolic function grade	Correlation coefficient (unitless) between change in intramyocardial fat, quantified by cardiac computed tomography (CT) as a percentage of myocardial volume, and change in diastolic function grade assessed by transthoracic echocardiography according to guideline-based criteria	Baseline to 6 months
Change in diastolic function grade	Change in diastolic function grade assessed by transthoracic echocardiography according to standard guideline-based criteria (including parameters such as E/e', left atrial volume index, and other measures of left ventricular filling pressures) between baseline and 6 months	Baseline to 6 months
Change in body composition	Change in total fat mass and lean body mass assessed by body composition analysis between baseline and 6 months	Baseline to 6 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)	Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration, measured in pg/mL using standard laboratory assays, between baseline and 6 months	Baseline to 6 months
Change in pericardial fat volume	Change in pericardial fat volume quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery	Baseline to 6 months
Correlation coefficient between change in intramyocardial fat and change in body weight	Correlation coefficient (unitless) between change in intramyocardial fat, quantified by cardiac CT as a percentage of myocardial volume, and change in body weight measured in kilograms	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Itshak Amsalem

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: SZMC-0044-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) sharing is currently undecided. Any future data sharing will depend on institutional policies, ethical approvals, and applicable data protection regulations. If shared, only de-identified data will be made available to qualified researchers upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No