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Clinical Trials/NCT04933188
NCT04933188
Recruiting
Not Applicable

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

RenJi Hospital1 site in 1 country200 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
RenJi Hospital
Enrollment
200
Locations
1
Primary Endpoint
investigate the change of global work efficiency (GWE) in overweight or obese patients
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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/m
  • 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.

Outcomes

Primary Outcomes

investigate the change of global work efficiency (GWE) in overweight or obese patients

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: within 24 hours of the recruitment

GWW will be assessed in overweight or obese patients and compare with lean controls

Study Sites (1)

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