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Left Ventricular HypertrophyMET-LVHNCT05719337

Multi-Modality Echocardiographic Techniques in Pathological Left Ventricular Hypertrophy Adults

An observational study of Left Ventricular Hypertrophy, run by First Hospital of China Medical University at 22 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Left Ventricular Hypertrophy
What is being tested?
Echocardiography
Type of treatment
Medical device
How many people
660 participants
Where
22 sitesChina
Study dates
1 Jan 2023to 5 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 1 country.

Chunyan Ma, Ph.D contact

+86 13998816448

cmu1h_mcy@126.com

22 sites in 1 country

China22 sites, 22 recruiting
  • Ansteel Group General Hospita

    Anshan, Liaoning

    Ying Liu, Ph.D

    Recruiting
  • Benxi Central Hospital

    Benxi, Liaoning

    Xingbin Wang

    Recruiting
  • Chaoyang Central Hospital

    Chaoyang, Liaoning

    Guixin Zhu

    Recruiting
  • Dalian Municipal Central Hospital

    Dalian, Liaoning

    Qingxiong Yue

    Recruiting
  • the Second Hospital of Dalian Medical University

    Dalian, Liaoning

    Yuhong Zhang

    Recruiting
  • Dandong Central Hospital

    Dandong, Liaoning

    Xin Jin

    Recruiting
  • Fushun Central Hospital

    Fushun, Liaoning

    Chen Zhang

    Recruiting
  • the Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

    Xiaoshan Zhang

    Recruiting
  • the First Affiliated Hospital of Jiamusi University

    Jiamusi, Heilongjiang

    Xin Yang

    Recruiting
  • the First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

    Yuhong Li

    Recruiting
  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

    Jing Yao

    Recruiting
  • Affiliated Central Hospital of Shenyang Medical College

    Shenyang, Liaoning

    Tong Zang

    Recruiting
  • Dadong Branch of First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

    Jiahui Ma

    Recruiting
  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

    Kuiran Gao

    Recruiting
  • the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

    Linwei Hong

    Recruiting
  • the First Hospital of China Medical Univeristy

    Shenyang, Liaoning

    Chunyan Ma, Ph.D

    Recruiting
  • the Second Affiliated Hospital of Shenyang Medical College

    Shenyang, Liaoning

    Ying Ding

    Recruiting
  • the Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Hongning Yin

    Recruiting
  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality

    Xin Guan

    Recruiting
  • Liao Jian Group Tie Mei General Hospital

    Tieling, Liaoning

    Sha Li

    Recruiting
  • Tieling Central Hospital

    Tieling, Liaoning

    Jie Liang

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

    Wuhan, Hubei

    Li Zhang, Ph.D

    Recruiting

Other trials in China

About this study

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)

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.

Read the 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.

Being tested
Echocardiography
Keywords
Pathological Left Ventricular Hypertrophy, Multi-modality Echocardiographic Parameters, Hypertensive Heart Disease, Hypertrophic Cardiomyopathy, Cardiac Amyloidosis, Fabry Disease
Medical subject headings
Hypertrophy, Left Ventricular, Cardiomyopathy, Hypertrophic, Amyloid Neuropathies, Familial, Fabry Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EchocardiographyDevice

    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.

Study groups in NCT05719337
Study groupRoleWhat they receive
Hypertensive heart disease groupSystolic 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.
Receives: Device: Echocardiography
Hypertrophic cardiomyopathy groupWall 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.
Receives: Device: Echocardiography
Cardiac amyloidosis groupClinical diagnosis of cardiac amyloidosis confirmed by blood tests or tissue biopsy.
Receives: Device: Echocardiography
Fabry disease groupClinical diagnosis of Fabray disease confirmed by blood biomarkers or genetic testing.
Receives: Device: Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 day after admission

Secondary outcomes (2)
  1. Strain parameters in all pathological LVH patients

    To evaluate the two-dimensional strain parameters of left ventricular and left atrium in all LVH patients.

    Measured: 1 day after admission

  2. Volume and mass parameters in all pathological LVH patients

    To evaluate the three-dimensional volume and mass parameters in all LVH patients.

    Measured: 1 day after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start1 Jan 2023
  3. Primary completion5 Aug 2024 (estimated)
  4. Study completion5 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05719337
Sponsor's protocol ID
MET-LVH-01
Acronym
MET-LVH
Status last verified
Feb 2023
First submitted
29 Jan 2023
Last updated
10 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Left Ventricular Hypertrophy, run by First Hospital of China Medical University at 22 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chunyan Ma, Ph.D (+86 13998816448, cmu1h_mcy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conventional echocardiographic parameters in all pathological LVH patients (time frame: 1 day after admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.

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