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Not yet recruitingNCT07565610Updated May 4, 2026

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

An observational study in Obesity, Diastolic Dysfunction and Heart Failure With Preserved Ejection Fraction (HFPEF), sponsored by Itshak Amsalem. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Itshak Amsalem · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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

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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 150 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Itshak Amsalem is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adults Undergoing Bariatric Surgery
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What researchers measure

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

  5. 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

    Time frame: Baseline to 6 months

  6. 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

    Time frame: Baseline to 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07565610
Lead sponsor
Itshak Amsalem
Responsible party
Itshak Amsalem (Principal Investigator, Shaare Zedek Medical Center) — Sponsor-investigator
First posted
May 4, 2026
Start date
May 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2028 (estimated)
Last update
May 4, 2026

Study contacts

Itshak Amsalem, MD
Contact
itshak1a@gmail.com
+972508229454

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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