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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Left Ventricular Hypertrophy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 660

Contacts and Locations

• Study Contact: Name: Chunyan Ma, Ph.D; Phone Number: +86 13998816448; Email: cmu1h_mcy@126.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Hongning Yin
  • Heilongjiang
    • Jiamusi, Heilongjiang, China
      • Recruiting
      • The First Affiliated Hospital of Jiamusi University
      • Contact: Xin Yang
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Li Zhang, Ph.D
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • Recruiting
      • The Affiliated Hospital of Inner Mongolia Medical University
      • Contact: Xiaoshan Zhang
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Jing Yao
  • Liaoning
    • Anshan, Liaoning, China
      • Recruiting
      • Ansteel Group General Hospita
      • Contact: Ying Liu, Ph.D
    • Benxi, Liaoning, China
      • Recruiting
      • Benxi Central Hospital
      • Contact: Xingbin Wang
    • Chaoyang, Liaoning, China
      • Recruiting
      • Chaoyang Central Hospital
      • Contact: Guixin Zhu
    • Dalian, Liaoning, China
      • Recruiting
      • The Second Hospital of Dalian Medical University
      • Contact: Yuhong Zhang
    • Dalian, Liaoning, China
      • Recruiting
      • Dalian Municipal Central Hospital
      • Contact: Qingxiong Yue
    • Dandong, Liaoning, China
      • Recruiting
      • Dandong Central Hospital
      • Contact: Xin Jin
    • Fushun, Liaoning, China
      • Recruiting
      • Fushun central hospital
      • Contact: Chen Zhang
    • Jinzhou, Liaoning, China
      • Recruiting
      • The First Affiliated Hospital Of Jinzhou Medical University
      • Contact: Yuhong Li
    • Shenyang, Liaoning, China
      • Recruiting
      • Liaoning cancer Hospital & Institute
      • Contact: Kuiran Gao
    • Shenyang, Liaoning, China
      • Recruiting
      • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
      • Contact: Linwei Hong
    • Shenyang, Liaoning, China
      • Recruiting
      • The Second Affiliated Hospital of Shenyang Medical College
      • Contact: Ying Ding
    • Shenyang, Liaoning, China
      • Recruiting
      • Affiliated Central Hospital of Shenyang Medical College
      • Contact: Tong Zang
    • Shenyang, Liaoning, China
      • Recruiting
      • Dadong Branch of First Affiliated Hospital of China Medical University
      • Contact: Jiahui Ma
    • Shenyang, Liaoning, China
      • Recruiting
      • the First Hospital of China Medical Univeristy
      • Contact: Chunyan Ma, Ph.D
    • Tieling, Liaoning, China
      • Recruiting
      • Liao Jian Group Tie Mei General Hospital
      • Contact: Sha Li
    • Tieling, Liaoning, China
      • Recruiting
      • Tieling Central Hospital
      • Contact: Jie Liang
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Chest Hospital
      • Contact: Xin Guan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with left ventricular hypertrophy (LVH) detected by echocardiography.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University
• Collaborators: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Li Zhang, Ph.D, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2023
• Primary Completion (ANTICIPATED): August 5, 2024
• Study Completion (ANTICIPATED): August 5, 2025

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hypertrophic Cardiomyopathy; Fabry Disease; Cardiac Amyloidosis; Pathological Left Ventricular Hypertrophy; Multi-modality Echocardiographic Parameters; Hypertensive Heart Disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Cardiomegaly; Hypertrophy; Hypertrophy, Left Ventricular
• Other Study ID Numbers: MET-LVH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No