A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetes, Prognosis. Basic parameters: 35 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes Mellitus
Overview
The aims of this study are to 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.
Detailed description
This study will recruit 1000 T2DM patients and 500 Prediabetes and 500 healthy controls. Assessing the left heart and right heart structure and function by speckle tracking echocardiography. Patients with T2DM were followed up for adverse cardiovascular outcome events (myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure). And the study aimed to 1. 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.
Primary outcome measures
- major adverse cardiovascular events [Time frame: through study completion, an average of 6 year]
Eligibility criteria
Inclusion criteria
people with T2DM according to the WHO 2006 criteria
Exclusion criteria
including history or symptoms of CAD valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04964713 · 2021 V1.0