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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorItshak Amsalem

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: Adults Undergoing Bariatric Surgery

Trial outcomes

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

Time frame
Baseline to 6 months

Secondary outcomes

1

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

Time frame
Baseline to 6 months
2

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

Time frame
Baseline to 6 months
3

Change in body composition

Change in total fat mass and lean body mass assessed by body composition analysis between baseline and 6 months

Time frame
Baseline to 6 months
4

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

Time frame
Baseline to 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Itshak Amsalem

Lead sponsor

Shaare Zedek Medical Center

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: