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NCT Number: NCT07565610

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

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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Key information

Conditions

Obesity Body Weight Diastolic Dysfunction Heart Failure With Preserved Ejection Fraction (HFpEF) Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Change in intramyocardial fat content assessed by cardiac CT

    Time frame: Baseline to 6 months

    Change in intramyocardial fat quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery

Secondary outcomes

  1. Correlation coefficient between change in intramyocardial fat and change in diastolic function grade

    Time frame: Baseline to 6 months

    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

  2. Change in diastolic function grade

    Time frame: Baseline to 6 months

    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

  3. Change in body composition

    Time frame: Baseline to 6 months

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

  4. Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)

    Time frame: Baseline to 6 months

    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

  5. Change in pericardial fat volume

    Time frame: Baseline to 6 months

    Change in pericardial fat volume quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery

  6. Correlation coefficient between change in intramyocardial fat and change in body weight

    Time frame: Baseline to 6 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Itshak Amsalem, MD

CONTACT

[email protected]

+972508229454

Sponsors and collaborators

Lead sponsor

Itshak Amsalem

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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