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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Overweight and Obesity

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04933188
ACFO2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

200 participants in 3 patient groups

control
Description:
Lean health controls with a BMI\<25kg/m2
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
overweight
Description:
patients with a BMI of 25-30kg/m2
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
obesity
Description:
patients with a BMI of over 30kg/m2
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

Trial contacts and locations

1

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Central trial contact

Hang Zhao

Data sourced from clinicaltrials.gov

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