Clinical trial NCT04933188: Early Detection of Myocardial Work Impairment in Obesity II(EARLY-MYO-OBESITY-II)
Official title: Early Detection of Myocardial Work Impairment in Patients With Overweight and Obesity (EARLY-MYO-OBESITY-II)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overweight and Obesity
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Ningbo Hangzhou Bay Hospital
name: Jiading Central Hospital
First posted: 2021-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: overweight or obese subjects referred to the endocrinology inpatients

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.

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/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.

Primary outcomes:
measure: investigate the change of global myocardial work index (GWI) in overweight or obese patients
timeFrame: within 24 hours of the recruitment
measure: investigate the change of global constructive work (GCW) in overweight or obese patients
timeFrame: within 24 hours of the recruitment
measure: investigate the change of global waste work (GWW) in overweight or obese patients
timeFrame: within 24 hours of the recruitment
measure: investigate the change of global work efficiency (GWE) in overweight or obese patients
timeFrame: within 24 hours of the recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Renji Hospital, Shanghai
name: Meng Jiang
role: STUDY_DIRECTOR
References: