Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05719337 |
| Other study ID # |
MET-LVH-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
August 5, 2025 |
Study information
| Verified date |
February 2023 |
| Source |
First Hospital of China Medical University |
| Contact |
Chunyan Ma, Ph.D |
| Phone |
+86 13998816448 |
| Email |
cmu1h_mcy[@]126.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 identification and risk assessment in LVH
patients.
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.
