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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933188
• Other study ID #: ACFO2020
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: RenJi Hospital
• Contact: Hang Zhao
• Phone: +8613764477850
• Email: zara_hang[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Diagnostic Test:
• Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure
Baseline and follow-up examination of echocardiography is to be performed on study subjects.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Jiading Central Hospital, Ningbo Hangzhou Bay Hospital

Country where clinical trial is conducted

China, 

Outcome

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