Multi-Modality Echocardiographic Techniques in Pathological Left Ventricular Hypertrophy Adults

NCT ID: NCT05719337

Last Updated: 2023-02-10

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

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Recruitment Status

UNKNOWN

Total Enrollment

660 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-08-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Left Ventricular Hypertrophy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Echocardiography

Intervention Type DEVICE

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.

Echocardiography

Intervention Type DEVICE

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.

Echocardiography

Intervention Type DEVICE

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.

Echocardiography

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chunyan Ma

Chief of Cardiovascular Ultrasound

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunyan Ma, Ph.D

Role: PRINCIPAL_INVESTIGATOR

the First Hospital of China Medical Univeristy

Li Zhang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

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the Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

the First Affiliated Hospital of Jiamusi University

Jiamusi, Heilongjiang, China

Site Status RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

the Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Site Status RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Ansteel Group General Hospita

Anshan, Liaoning, China

Site Status RECRUITING

Benxi Central Hospital

Benxi, Liaoning, China

Site Status RECRUITING

Chaoyang Central Hospital

Chaoyang, Liaoning, China

Site Status RECRUITING

Dalian Municipal Central Hospital

Dalian, Liaoning, China

Site Status RECRUITING

the Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

Dandong Central Hospital

Dandong, Liaoning, China

Site Status RECRUITING

Fushun Central Hospital

Fushun, Liaoning, China

Site Status RECRUITING

the First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Site Status RECRUITING

Affiliated Central Hospital of Shenyang Medical College

Shenyang, Liaoning, China

Site Status RECRUITING

Dadong Branch of First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Site Status RECRUITING

the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Site Status RECRUITING

the First Hospital of China Medical Univeristy

Shenyang, Liaoning, China

Site Status RECRUITING

the Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China

Site Status RECRUITING

Liao Jian Group Tie Mei General Hospital

Tieling, Liaoning, China

Site Status RECRUITING

Tieling Central Hospital

Tieling, Liaoning, China

Site Status RECRUITING

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunyan Ma, Ph.D

Role: CONTACT

+86 13998816448

Facility Contacts

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Hongning Yin

Role: primary

Xin Yang

Role: primary

Li Zhang, Ph.D

Role: primary

Xiaoshan Zhang

Role: primary

Jing Yao

Role: primary

Ying Liu, Ph.D

Role: primary

Xingbin Wang

Role: primary

Guixin Zhu

Role: primary

Qingxiong Yue

Role: primary

Yuhong Zhang

Role: primary

Xin Jin

Role: primary

Chen Zhang

Role: primary

Yuhong Li

Role: primary

Tong Zang

Role: primary

Jiahui Ma

Role: primary

Kuiran Gao

Role: primary

Linwei Hong

Role: primary

Chunyan Ma, Ph.D

Role: primary

Ying Ding

Role: primary

Sha Li

Role: primary

Jie Liang

Role: primary

Xin Guan

Role: primary

Other Identifiers

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MET-LVH-01

Identifier Type: -

Identifier Source: org_study_id

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