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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
Change in body composition
Change 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)
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
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: