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

NCT ID: NCT04933188

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight and Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control

Lean health controls with a BMI\<25kg/m2

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

Intervention Type DIAGNOSTIC_TEST

Baseline and follow-up examination of echocardiography is to be performed on study subjects.

overweight

patients with a BMI of 25-30kg/m2

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

Intervention Type DIAGNOSTIC_TEST

Baseline and follow-up examination of echocardiography is to be performed on study subjects.

obesity

patients with a BMI of over 30kg/m2

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

Intervention Type DIAGNOSTIC_TEST

Baseline and follow-up examination of echocardiography is to be performed on study subjects.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ningbo Hangzhou Bay Hospital

UNKNOWN

Sponsor Role collaborator

Jiading Central Hospital

UNKNOWN

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Meng Jiang

Role: STUDY_DIRECTOR

RenJi Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hang Zhao

Role: CONTACT

+8613764477850

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hang Zhao

Role: primary

+8613764477850

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ACFO2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.