Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07565610
Enrollment
150
Registered
2026-05-04
Start date
2026-05-01
Completion date
2028-05-01
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Itshak Amsalem
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in intramyocardial fat content assessed by cardiac CTBaseline to 6 monthsChange in intramyocardial fat quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery

Secondary

MeasureTime frameDescription
Correlation coefficient between change in intramyocardial fat and change in diastolic function gradeBaseline to 6 monthsCorrelation 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
Change in diastolic function gradeBaseline to 6 monthsChange 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
Change in body compositionBaseline to 6 monthsChange in total fat mass and lean body mass assessed by body composition analysis between baseline and 6 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)Baseline to 6 monthsChange in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration, measured in pg/mL using standard laboratory assays, between baseline and 6 months
Change in pericardial fat volumeBaseline to 6 monthsChange in pericardial fat volume quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery
Correlation coefficient between change in intramyocardial fat and change in body weightBaseline to 6 monthsCorrelation 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

Contacts

CONTACTItshak Amsalem, MD
itshak1a@gmail.com+972508229454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026