NCT05719337

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
660

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

22 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

January 29, 2023

Last Update Submit

February 8, 2023

Conditions

Keywords

Pathological Left Ventricular HypertrophyMulti-modality Echocardiographic ParametersHypertensive Heart DiseaseHypertrophic CardiomyopathyCardiac AmyloidosisFabry Disease

Outcome Measures

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.

    1 day after admission

Secondary Outcomes (2)

  • Strain parameters in all pathological LVH patients

    1 day after admission

  • Volume and mass parameters in all pathological LVH patients

    1 day after admission

Study Arms (4)

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

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.

Cardiac amyloidosis groupFabry disease groupHypertensive heart disease groupHypertrophic cardiomyopathy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

the Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

the First Affiliated Hospital of Jiamusi University

Jiamusi, Heilongjiang, China

RECRUITING

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

Wuhan, Hubei, China

RECRUITING

the Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

Ansteel Group General Hospita

Anshan, Liaoning, China

RECRUITING

Benxi Central Hospital

Benxi, Liaoning, China

RECRUITING

Chaoyang Central Hospital

Chaoyang, Liaoning, China

RECRUITING

Dalian Municipal Central Hospital

Dalian, Liaoning, China

RECRUITING

the Second Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

Dandong Central Hospital

Dandong, Liaoning, China

RECRUITING

Fushun Central Hospital

Fushun, Liaoning, China

RECRUITING

the First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

RECRUITING

Affiliated Central Hospital of Shenyang Medical College

Shenyang, Liaoning, China

RECRUITING

Dadong Branch of First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

RECRUITING

the First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

RECRUITING

the First Hospital of China Medical Univeristy

Shenyang, Liaoning, China

RECRUITING

the Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China

RECRUITING

Liao Jian Group Tie Mei General Hospital

Tieling, Liaoning, China

RECRUITING

Tieling Central Hospital

Tieling, Liaoning, China

RECRUITING

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left VentricularCardiomyopathy, HypertrophicAmyloid Neuropathies, FamilialFabry Disease

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCardiomyopathiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis DeficienciesSphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersVascular DiseasesGenetic Diseases, X-LinkedLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Chunyan Ma, Ph.D

    the First Hospital of China Medical Univeristy

    PRINCIPAL INVESTIGATOR
  • Li Zhang, Ph.D

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunyan Ma, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiovascular Ultrasound

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

January 1, 2023

Primary Completion

August 5, 2024

Study Completion

August 5, 2025

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations