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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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04933188
Enrollment
200
Registered
2021-06-21
Start date
2019-05-01
Completion date
2024-12-31
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

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.

Interventions

DIAGNOSTIC_TESTMyocardial 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.

Sponsors

Ningbo Hangzhou Bay Hospital
CollaboratorUNKNOWN
Jiading Central Hospital
CollaboratorUNKNOWN
RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
investigate the change of global myocardial work index (GWI) in overweight or obese patientswithin 24 hours of the recruitmentGWI 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 patientswithin 24 hours of the recruitmentGCW 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 patientswithin 24 hours of the recruitmentGWW will be assessed in overweight or obese patients and compare with lean controls
investigate the change of global work efficiency (GWE) in overweight or obese patientswithin 24 hours of the recruitmentGWE will be assessed in overweight or obese patients and compare with lean controls

Countries

China

Contacts

Primary ContactHang Zhao
zara_hang@163.com+8613764477850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026