ObesityNCT07565610
Changes in Intramyocardial Fat Assessed by Cardiac CT Before and After Bariatric Surgery and Their Relationship With Cardiac Diastolic Function
An observational study of Obesity and Diastolic Dysfunction, run by Itshak Amsalem.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Diastolic Dysfunction, Heart Failure With Preserved Ejection Fraction (HFPEF)
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to May 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults Undergoing Bariatric Surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 6 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start10 Oct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Itshak Amsalem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Itshak Amsalem, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565610
- Sponsor's protocol ID
- SZMC-0044-26
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.