MET-LVH: Multi-Modality Echocardiographic Techniques in Pathological Left Ventricular Hypertrophy Adults

Sponsor

First Hospital of China Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05719337

Collaborator

Wuhan Union Hospital, China (Other)

660

Enrollment

Locations

31.1

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Hypertrophy	Device: Echocardiography

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

660 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Characteristics of the Multi-Modality Echocardiographic Techniques in Chinese Adults With Pathological Left Ventricular Hypertrophy - a Prospective, Multicenter, Clinical Study (MET-LVH Study)

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Aug 5, 2024

Anticipated Study Completion Date :

Aug 5, 2025

Arms and Interventions

Arm	Intervention/Treatment
Hypertensive heart disease group Systolic blood pressure exceeded 140 mmHg and/or diastolic blood pressure exceeded 90 mmHg, or a history of systemic hypertension in the absence of other cardiac or systemic disease was described as hypertension.	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.
Hypertrophic cardiomyopathy group Wall thickness≥15 mm in the absence of other causes of hypertrophy in a non-dilated left ventricle (LV) defines HCM. End diastolic wall thickness≥13 mm can be diagnostic if there is a family history of HCM or a known disease-causing genetic mutation.	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.
Cardiac amyloidosis group Clinical diagnosis of cardiac amyloidosis confirmed by blood tests or tissue biopsy.	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.
Fabry disease group Clinical diagnosis of Fabray disease confirmed by blood biomarkers or genetic testing.	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.

Outcome Measures

Primary Outcome Measures

Conventional echocardiographic parameters in all pathological LVH patients [1 day after admission]
To evaluate the conventional two-dimensional, color Doppler, spectral Doppler and tissue Doppler echocardiographic parameters in all pathological LVH patients.

Secondary Outcome Measures

Strain parameters in all pathological LVH patients [1 day after admission]
To evaluate the two-dimensional strain parameters of left ventricular and left atrium in all LVH patients.
Volume and mass parameters in all pathological LVH patients [1 day after admission]
To evaluate the three-dimensional volume and mass parameters in all LVH patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	the Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
2	the First Affiliated Hospital of Jiamusi University	Jiamusi	Heilongjiang	China
3	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China
4	the Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia	China
5	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China
6	Ansteel Group General Hospita	Anshan	Liaoning	China
7	Benxi Central Hospital	Benxi	Liaoning	China
8	Chaoyang Central Hospital	Chaoyang	Liaoning	China
9	Dalian Municipal Central Hospital	Dalian	Liaoning	China
10	the Second Hospital of Dalian Medical University	Dalian	Liaoning	China
11	Dandong Central Hospital	Dandong	Liaoning	China
12	Fushun Central Hospital	Fushun	Liaoning	China
13	the First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning	China
14	Affiliated Central Hospital of Shenyang Medical College	Shenyang	Liaoning	China
15	Dadong Branch of First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China
16	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning	China
17	the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning	China
18	the First Hospital of China Medical Univeristy	Shenyang	Liaoning	China
19	the Second Affiliated Hospital of Shenyang Medical College	Shenyang	Liaoning	China
20	Liao Jian Group Tie Mei General Hospital	Tieling	Liaoning	China
21	Tieling Central Hospital	Tieling	Liaoning	China
22	Tianjin Chest Hospital	Tianjin	Tianjin	China

Sponsors and Collaborators

First Hospital of China Medical University
Wuhan Union Hospital, China

Investigators

Principal Investigator: Chunyan Ma, Ph.D, the First Hospital of China Medical Univeristy
Principal Investigator: Li Zhang, Ph.D, Wuhan Union Hospital, China