Detecting heart function changes in overweight and obese patients

Early Detection of Myocardial Work Impairment in Patients With Overweight and Obesity (EARLY-MYO-OBESITY-II)

This study is trying to see how heart function changes in overweight and obese people to catch any early signs of heart problems before they become serious.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04933188 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate how cardiac structure and function change in individuals with overweight or obesity. It focuses on early detection of preclinical cardiac dysfunction and its relationship with insulin resistance and other clinical characteristics. Using a novel technique for myocardial work assessment through echocardiography, the study will evaluate myocardial performance in this population. The goal is to understand how these factors may influence cardiac mechanics before any noticeable impairment in heart function occurs.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a BMI between 25 and 40 who do not exhibit any cardiac symptoms.

Not a fit: Patients with existing cardiac conditions, such as significant coronary artery disease or diabetes, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and intervention for heart issues in overweight and obese patients.

How similar studies have performed: Other studies have shown promise in using myocardial work assessment techniques in various cardiac conditions, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* All patients were older than 18 without any cardiac symptoms.
* The diagnosis of overweight was established when body mass index (BMI) of 25 to 30 kg/m2.
* Obese was defined as a BMI of 30 kg/m2 or higher.

Exclusion Criteria:

* diagnosis of type 2-Diabetes Mellitus according to the American Diabetes Association criteria;
* left ventricular ejection fraction\<50% on echocardiography;
* arrythmia on electrocardiogram;
* severe valvular stenosis or regurgitation;
* history of coronary disease (defined as stenosis\>50%) or myocardial infarction;
* stress induced wall motion abnormality on echocardiography, coronary artery stenosis \>50% on coronary CT or angiography with Framingham risk score of \>10;
* pacemaker or defibrillator implantation;
* the presence of bundle branch block;
* severe infection or renal dysfunction with an estimated glomerular filtration rate \< 60 ml/min/1.73 m2);
* inadequate image quality on echocardiography.

Where this trial is running

Shanghai, Shanghai

• Renji Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Hang Zhao

Conditions Overweight and Obesity