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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05062811
Other study ID # MW-China2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date December 1, 2022

Study information

Verified date September 2021
Source Chongqing Medical University
Contact Dongying Zhang
Phone +8613608398395
Email zdy.chris@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hypertension is a serious threat to human health and a major global economic burden. Chronic hypertension can cause left ventricular remodeling and loss of function, eventually leading to heart failure. Exploring the early changes and mechanisms of left ventricular cardiac function caused by hypertension, and to identify individuals who may develop into serious heart injury, may play a positive role in the early prevention and control of heart failure caused by hypertension. Therefore, this study intend to use two dimensional speckle tracking technology, a non-invasive method to measure left ventricular pressure-strain loop to quantitatively reflect cardiac work index , to study different hypertension patients with normal left ventricular ejection fraction the change of the global and local cardiac work, and the influence of aterosclerosis in the patients to myocardial work, and explore their relationship with ventricular remodeling and abnormal diastolic function. To improve the understanding of the pathophysiology of hypertension, hypertensive heart disease and heart failure, and to provide scientific support for the early prevention and control of such diseases. Myocardial work analysis Echocardiography plays a central role in the evaluation of patients with cardiovascular disease. Echocardiography is widely available and allows characterization of the functional and structural of heart. Thus, assessment of left lentricular (LV) global longitudinal strain (LVGLS) and Myocardial work indexes has proven benefit for both diagnosis and risk in hypertension patients.


Description:

Hypertension is a serious threat to human health and a major global economic burden.Chronic hypertension can cause left ventricular remodeling and loss of function, eventually leading to heart failure. Ventricular remodeling in hypertensive patients is an adaptive and decompensating response to persistent elevated blood pressure and increased myocardial work load. Exploring the early changes and mechanisms of left ventricular cardiac function caused by hypertension, and to identify individuals who may develop into serious heart injury, may play a positive role in the early prevention and control of heart failure caused by hypertension.Therefore, this study intend to use two dimensional speckle tracking technology, a non-invasive method to measure left ventricular pressure-strain loop to quantitatively reflect cardiac work index , to study different hypertension patients with normal left ventricular ejection fraction (including hypertension without heart damage performance with different degree of high blood pressure, hypertension with diastolic dysfunction , hypertension with left ventricular hypertrophy ) the change of the global and local cardiac work, and the influence of aterosclerosis in the patients to myocardial work, and explore their relationship with ventricular remodeling and abnormal diastolic function.To improve the understanding of the pathophysiology of hypertension, hypertensive heart disease and heart failure, and to provide scientific support for the early prevention and control of such diseases.Now days, Echocardiography plays a central role in the evaluation of patients with cardiovascular disease. Echocardiography is widely available and allows characterization of the functional and structural of heart. Thus, assessment of left lentricular (LV) global longitudinal strain (LVGLS) and Myocardial work indexes has proven benefit for both diagnosis and risk in hypertension patients. Myocardial work indexes have four indexes to evaluate different function of lentricular. However, there is still no research investigating the the relationship between blood pressure and Myocardial work indexes in patients with different levels of blood pressure.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1.patients of outpatient clinic 2.65=Adult aged =18years old; Exclusion Criteria: The exclusion criteria were patients aged less than 18 or greater than 65 years, previous diagnosis of diabetes mellitus, coronary artery disease, valve heart disease, primary cardiomyopathies, arterial fibrillation, left ventricular ejection fraction<50% , inadequate echocardiographic imaging. The patients with disease leading low PP(=30mmHg) were special examined and excluded, including pericardial disease, severe mitral stenosis, aortic stenosis, severe chronic heart failure, blood loss and shock etc. A total of 40 patients were exclude from the study according to the preset criteria.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The First Affiliated Hospital of Chongqing Medical University Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global work index Global work index by non-invasive pressure-strain loops: a novel parameter to assess left ventricular performance in the early stages of heart failure with preserved or mid-range ejection fraction after acute myocardial infarction On admission
Primary Global constructed work Global constructive work represented the sum of positive work due to myocardial shortening during systole and negative work due to lengthening during isovolumic relaxation. On admission
Primary Global longitudinal strain The assessment of global longitudinal strain (GLS) from speckle-tracking analysis of 2-dimensional echocardiography has become a clinically feasible alternative to LVEF for the measurement of myocardial function. On admission
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