Clinical trial NCT05719337: Multi-Modality Echocardiographic Techniques in Pathological Left Ventricular Hypertrophy Adults
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Ventricular Hypertrophy
Keywords: Pathological Left Ventricular Hypertrophy
Multi-modality Echocardiographic Parameters
Hypertensive Heart Disease
Hypertrophic Cardiomyopathy
Cardiac Amyloidosis
Fabry Disease
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
First posted: 2023-02-08
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with left ventricular hypertrophy (LVH) detected by echocardiography.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Conventional echocardiographic parameters in all pathological LVH patients
timeFrame: 1 day after admission
Secondary outcomes:
measure: Strain parameters in all pathological LVH patients
timeFrame: 1 day after admission
measure: Volume and mass parameters in all pathological LVH patients
timeFrame: 1 day after admission
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the Second Hospital of Hebei Medical University
state: Hebei
city: Jiamusi
country: China
facility: the First Affiliated Hospital of Jiamusi University
state: Heilongjiang
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Hohhot
country: China
facility: the Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Anshan
country: China
facility: Ansteel Group General Hospita
state: Liaoning
city: Benxi
country: China
facility: Benxi Central Hospital
state: Liaoning
city: Chaoyang
country: China
facility: Chaoyang Central Hospital
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Dalian
country: China
facility: the Second Hospital of Dalian Medical University
state: Liaoning
city: Dandong
country: China
facility: Dandong Central Hospital
state: Liaoning
city: Fushun
country: China
facility: Fushun Central Hospital
state: Liaoning
city: Jinzhou
country: China
facility: the First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: Affiliated Central Hospital of Shenyang Medical College
state: Liaoning
city: Shenyang
country: China
facility: Dadong Branch of First Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Shenyang
country: China
facility: the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: the First Hospital of China Medical Univeristy
state: Liaoning
city: Shenyang
country: China
facility: the Second Affiliated Hospital of Shenyang Medical College
state: Liaoning
city: Tieling
country: China
facility: Liao Jian Group Tie Mei General Hospital
state: Liaoning
city: Tieling
country: China
facility: Tieling Central Hospital
state: Liaoning
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
Study officials:
affiliation: the First Hospital of China Medical Univeristy
name: Chunyan Ma, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Union Hospital, China
name: Li Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: