Early Detection of Myocardial Work Impairment in Obesity II(EARLY-MYO-OBESITY-II)

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Diagnostic Test: Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure

• Registration Number: NCT04933188
• Lead Sponsor: RenJi Hospital

Brief Summary

This prospective study intends to explore the change of cardiac structure and function in the cohort of overweight or obesity patients, and determine the impact of clinical characteristics on cardiac remodeling and mechanics.

Detailed Description

Obesity significantly increases the risk for heart failure. Early detection of preclinical cardiac dysfunction in overweight or obesity and understanding its association with insulin resistance are of great importance.Recently, a novel technique for myocardial work (MW) assessment has been introduced to evaluate myocardial performance. To date, change of MW has been described in several cardiac conditions including dilated cardiomyopathy, significant coronary arterial diseases, and hypertrophic cardiomyopathy, which implies regional or global myocardial dysfunction. In this study, we aimed to explore the alteration of MW in overweight or obese adults and to determine whether insulin resistance or other clinical risk factors may impact myocardial mechanics before impairment of systolic function.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure	Lean health controls with a BMI\<25kg/m2
overweight	Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure	patients with a BMI of 25-30kg/m2
obesity	Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure	patients with a BMI of over 30kg/m2

Primary Outcome Measures

Name	Time	Method
investigate the change of global work efficiency (GWE) in overweight or obese patients	within 24 hours of the recruitment	GWE will be assessed in overweight or obese patients and compare with lean controls
investigate the change of global myocardial work index (GWI) in overweight or obese patients	within 24 hours of the recruitment	GWI derived from echocardiography will be assessed in overweight or obese patients and compare with lean controls
investigate the change of global constructive work (GCW) in overweight or obese patients	within 24 hours of the recruitment	GCW will be assessed in overweight or obese patients and compare with lean controls
investigate the change of global waste work (GWW) in overweight or obese patients	within 24 hours of the recruitment	GWW will be assessed in overweight or obese patients and compare with lean controls

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China