Changes in Intramyocardial Fat Assessed by Cardiac CT Before and After Bariatric Surgery and Their Relationship With Cardiac Diastolic Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Change in intramyocardial fat content assessed by cardiac CT
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Adults Undergoing Bariatric Surgery
结局指标
主要结局
Change in intramyocardial fat content assessed by cardiac CT
时间窗: Baseline to 6 months
Change in intramyocardial fat quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery
次要结局
- Correlation coefficient between change in intramyocardial fat and change in diastolic function grade(Baseline to 6 months)
- Change in diastolic function grade(Baseline to 6 months)
- Change in body composition(Baseline to 6 months)
- Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)(Baseline to 6 months)
- Change in pericardial fat volume(Baseline to 6 months)
- Correlation coefficient between change in intramyocardial fat and change in body weight(Baseline to 6 months)
研究者
Itshak Amsalem
Principal Investigator
Shaare Zedek Medical Center