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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05719337
Other study ID # MET-LVH-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date August 5, 2025

Study information

Verified date February 2023
Source First Hospital of China Medical University
Contact Chunyan Ma, Ph.D
Phone +86 13998816448
Email cmu1h_mcy@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This multicenter clinical study aims to evaluate the multi-modality echocardiographic parameters in patients with different pathological left ventricular hypertrophy (LVH) and investigate the correlation between echocardiographic parameters and different etiologies, providing an important theoretical basis for early identification and risk assessment in LVH patients.


Description:

Left ventricular hypertrophy (LVH) is an abnormal increase in the mass of the left ventricular myocardium, and its presence is associated with poor outcomes and ventricular arrhythmias. It is commonly seen in hypertension and aortic stenosis due to persistent pressure overload. In addition, it can also be found in genetic diseases and metabolic diseases, such as hypertrophic cardiomyopathy, cardiac amyloidosis and Fabry disease. Although patients with the latter type of LVH may often have normal loading conditions, there is significant heterogeneity in phenotypes and prognosis due to etiological variability. Hence for LVH patients, early identification of the underlying causes, effective intervention, follow up and surveillance may reduce mortality and improve survival. Echocardiography is the initial imaging modality for evaluation of cardiovascular diseases. And it plays an important role in the detection of LVH and potential causes in current clinical practice. Nevertheless, the feasibility of discriminatory for different diseases is limited by the fact that overlapping LVH in different conditions can often lead to diagnostic ambiguity. There is an urgent need to find echocardiographic parameters with high specificity to assist in the etiological diagnosis of patients with pathological LVH. Patients with LVH commonly associate with left ventricular diastolic dysfunction, causing changes in the structure and function of the left atrium prior to abnormal left ventricular ejection fraction. Left atrium function at reservoir, conduit and booster phases can be noninvasively quantify by speckle tracking echocardiography. However, there is incomplete information on left atrium strain characteristics in patients with LV pathological hypertrophy. The myocardial longitudinal strain parameters derived from speckle tracking echocardiography is a sensitive noninvasive method of assessing left ventricular myocardial performance. The relative "apical sparing" can be easily visualized for patients with cardiac amyloidosis. The reduced longitudinal strain in the basal lateral wall could be found at the very early stages of Fabry disease. Hence the specific manifestations derived from longitudinal strain mapping can assist in the differentiate patients from various causes of LVH. And left ventricular volume and mass index assessed by three-dimension echocardiography are independently associated with adverse outcomes of LVH patients. Therefore, appropriate utilization of multi-modality echocardiography techniques is fundamental to accurate diagnosis as well as longitudinal care of pathological LVH patients. However, a great deal of studies were based on small samples and single center. There is lack of defined diagnostic results based on multi-modality echocardiography and comprehensive markers derived from large-scale study. In this study, we expected to provide a set of parameters for different etiology by including patients with different pathological LVH based on multi-modality echocardiography, so as to assisting in early identification and risk assessment in LVH patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 660
Est. completion date August 5, 2025
Est. primary completion date August 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years old; - A wall thickness = 12mm in one or more LV myocardial segments as measured by 2D echocardiography. - Patients with definite diagnosis of hypertensive heart disease, hypertrophic cardiomyopathy, cardiac amyloidosis or Fabry disease. Exclusion Criteria: - Patients with severe valvular disease, congenital heart disease, aortic coarctation, multiple Takayasu arteritis, or other cardiovascular diseases that may cause ventricular hypertrophy; - Hypertrophy of myocardium caused by high intensity exercise; - Poor ultrasonic image quality, which cannot meet analysis requirement.

Study Design


Intervention

Device:
Echocardiography
Two-dimensional, color Doppler, spectral Doppler, tissue Doppler and three-dimensional echocardiographic image recordings will be taken using a Philips Epiq 7C echocardiography device and X5-1 probe. Conventional parameters, additional parameters, and strain analyzes will be performed by TomTec AutoStrain Suite Software.

Locations

Country Name City State
China Ansteel Group General Hospita Anshan Liaoning
China Benxi Central Hospital Benxi Liaoning
China Chaoyang Central Hospital Chaoyang Liaoning
China Dalian Municipal Central Hospital Dalian Liaoning
China the Second Hospital of Dalian Medical University Dalian Liaoning
China Dandong Central Hospital Dandong Liaoning
China Fushun Central Hospital Fushun Liaoning
China the Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia
China the First Affiliated Hospital of Jiamusi University Jiamusi Heilongjiang
China the First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning
China Nanjing Drum Tower Hospital Nanjing Jiangsu
China Affiliated Central Hospital of Shenyang Medical College Shenyang Liaoning
China Dadong Branch of First Affiliated Hospital of China Medical University Shenyang Liaoning
China Liaoning Cancer Hospital & Institute Shenyang Liaoning
China the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang Liaoning
China the First Hospital of China Medical Univeristy Shenyang Liaoning
China the Second Affiliated Hospital of Shenyang Medical College Shenyang Liaoning
China the Second Hospital of Hebei Medical University Shijiazhuang Hebei
China Tianjin Chest Hospital Tianjin Tianjin
China Liao Jian Group Tie Mei General Hospital Tieling Liaoning
China Tieling Central Hospital Tieling Liaoning
China Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
First Hospital of China Medical University Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Conventional echocardiographic parameters in all pathological LVH patients To evaluate the conventional two-dimensional, color Doppler, spectral Doppler and tissue Doppler echocardiographic parameters in all pathological LVH patients. 1 day after admission
Secondary Strain parameters in all pathological LVH patients To evaluate the two-dimensional strain parameters of left ventricular and left atrium in all LVH patients. 1 day after admission
Secondary Volume and mass parameters in all pathological LVH patients To evaluate the three-dimensional volume and mass parameters in all LVH patients. 1 day after admission
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