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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Diagnostic test: Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Hang Zhao; Phone Number: +8613764477850; Email: zara_hang@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital
      • Contact: Hang Zhao; Phone Number: +8613764477850; Email: zara_hang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

overweight or obese subjects referred to the endocrinology inpatients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control; Lean health controls with a BMI<25kg/m2	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.
overweight; patients with a BMI of 25-30kg/m2	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.
obesity; patients with a BMI of over 30kg/m2	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Ningbo Hangzhou Bay Hospital; Jiading Central Hospital
• Investigators: Study Director: Meng Jiang, Renji Hospital, Shanghai

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: ACFO2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No