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RecruitingNCT05719337MET-LVHUpdated Feb 10, 2023

Multi-Modality Echocardiographic Techniques in Pathological Left Ventricular Hypertrophy Adults

An observational study in Left Ventricular Hypertrophy, sponsored by First Hospital of China Medical University. Recruiting at 22 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by First Hospital of China Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
660
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Left Ventricular Hypertrophy

Keywords

  • Pathological Left Ventricular Hypertrophy
  • Multi-modality Echocardiographic Parameters
  • Hypertensive Heart Disease
  • Hypertrophic Cardiomyopathy
  • Cardiac Amyloidosis
  • Fabry Disease
03

In context

Hypertrophy, Left Ventricular

162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.

This study's planned enrollment of 660 is above the median of 198 across 60 observational studies indexed under Hypertrophy, Left Ventricular.

Browse Hypertrophy, Left Ventricular studies →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
660 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • Cardiac amyloidosis group

    Clinical diagnosis of cardiac amyloidosis confirmed by blood tests or tissue biopsy.

    Device: Echocardiography

  • Fabry disease group

    Clinical diagnosis of Fabray disease confirmed by blood biomarkers or genetic testing.

    Device: Echocardiography

Interventions

  • DeviceEchocardiography

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 1 day after admission

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 1 day after admission

07

Study locations

22 of 22 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05719337
Lead sponsor
First Hospital of China Medical University
Responsible party
Chunyan Ma (Chief of Cardiovascular Ultrasound, First Hospital of China Medical University) — Principal investigator
First posted
Feb 8, 2023
Start date
Jan 1, 2023
Primary completion
Aug 5, 2024 (estimated)
Completion
Aug 5, 2025 (estimated)
Last update
Feb 10, 2023

Study contacts

Chunyan Ma, Ph.D
Contact
cmu1h_mcy@126.com
+86 13998816448
Chunyan Ma, Ph.D
principal investigator · the First Hospital of China Medical Univeristy
Li Zhang, Ph.D
principal investigator · Wuhan Union Hospital, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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