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.
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.
22 sites in 1 country
China22 sites, 22 recruiting
- 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
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.
- Conditions
- Left Ventricular Hypertrophy
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Echocardiography | |
| 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. Receives: Device: Echocardiography | |
| Cardiac amyloidosis group | Clinical diagnosis of cardiac amyloidosis confirmed by blood tests or tissue biopsy. Receives: Device: Echocardiography | |
| Fabry disease group | Clinical 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.
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)
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
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.
- First posted8 Feb 2023
- Study start1 Jan 2023
- Primary completion5 Aug 2024 (estimated)
- Study completion5 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Chunyan Ma, First Hospital of China Medical University
- Investigators
- Chunyan Ma, Ph.D, Principal investigator, the First Hospital of China Medical UniveristyLi Zhang, Ph.D, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05719337
- Acronym / sponsor ID
- MET-LVH / MET-LVH-01
- Conditions
- Left Ventricular Hypertrophy
- Keywords
- Pathological Left Ventricular Hypertrophy, Multi-modality Echocardiographic Parameters, Hypertensive Heart Disease, Hypertrophic Cardiomyopathy, Cardiac Amyloidosis, Fabry Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 5 Aug 2024 (estimated)
- Study completion
- 5 Aug 2025 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypertensive heart disease group | – | Device: EchocardiographySystolic 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. |
| Hypertrophic cardiomyopathy group | – | Device: EchocardiographyWall 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. |
| Cardiac amyloidosis group | – | Device: EchocardiographyClinical diagnosis of cardiac amyloidosis confirmed by blood tests or tissue biopsy. |
| Fabry disease group | – | Device: EchocardiographyClinical diagnosis of Fabray disease confirmed by blood biomarkers or genetic testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with left ventricular hypertrophy (LVH) detected by echocardiography.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyTwo-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. | Device | Cardiac amyloidosis group, Fabry disease group, Hypertensive heart disease group, Hypertrophic cardiomyopathy group |
Primary outcome
Conventional echocardiographic parameters in all pathological LVH patients
Time frame: 1 day after admission
To evaluate the conventional two-dimensional, color Doppler, spectral Doppler and tissue Doppler echocardiographic parameters in all pathological LVH patients.
2 secondary outcomes
Strain parameters in all pathological LVH patients
Time frame: 1 day after admission
Volume and mass parameters in all pathological LVH patients
Time frame: 1 day after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunyan Ma, Ph.D principal investigator
the First Hospital of China Medical Univeristy
Li Zhang, Ph.D principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
22 sites in 1 country: see every site and its status.
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.