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Clinical Trials/NCT04112511
NCT04112511
Completed
Not Applicable

Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

AHEPA University Hospital1 site in 1 country250 target enrollmentMarch 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertrophic Cardiomyopathy
Sponsor
AHEPA University Hospital
Enrollment
250
Locations
1
Primary Endpoint
Implantable cardioverter defibrillator therapy
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of the study is to investigate the potential correlations of global longitudinal strain and peak left atrial strain, measured by speckle tracking echocardiography with the severity of hypertrophic cardiomyopathy and the risk for arrhythmias.

Specifically the investigational questions are:

  1. Is there a correlation between myocardial deformation parameters of the left heart chambers with other important ultrasound parameters (eg maximal wall thickness, presence of subaortic obstruction, etc.) in patients with hypertrophic cardiomyopathy?
  2. Is there a correlation between myocardial deformation parameters of the left heart chambers and the symptomatology or functional capacity of patients with hypertrophic cardiomyopathy?
  3. Is there a correlation between the myocardial deformation parameters of the left heart chambers and the exercise capacity, as evidenced by the cardiopulmonary exercise test, in patients with hypertrophic cardiomyopathy?
  4. Is there a correlation between myocardial deformation parameters of the left heart chambers with the risk of ventricular or supraventricular arrhythmias in patients with hypertrophic cardiomyopathy?
  5. Is there a correlation between myocardial deformation parameters of the left heart chambers and risk factors for sudden death?

Detailed Description

Myocardial deformation parameters of the left heart chambers are of particular clinical importance because of their possible association with the severity of HCM and the presence of arrhythmias. However,current literature appears conflicting. This is a prospective cohort study aiming to examine the echocardiographic parameters of myocardial deformation, estimated by the "speckle tracking" method, and their correlation with clinical presentation and symptomatology, other imaging parameters, exercise capacity, arrhythmias (ventricular or supraventricular) and risk factors for sudden death in patients with hypertrophic cardiomyopathy. Although, similar efforts have been made in international literature, they are scarce and their results contradictory. The present study is the first to be performed in a Greek population, a fact that is particularly important given the genetic heterogeneity of the disease.

Registry
clinicaltrials.gov
Start Date
March 1, 2015
End Date
May 5, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas Zegkos

Medical Doctor, Resident in Cardiology

AHEPA University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with diagnosed hypertrophic cardiomyopathy

Exclusion Criteria

  • Concomitant severe valvular heart disease
  • Prior myocardial infarction
  • History of atrial fibrillation

Outcomes

Primary Outcomes

Implantable cardioverter defibrillator therapy

Time Frame: 3 years

Aproppriate Implantable cardioverter defibrillator therapy

Cardiovascular mortality

Time Frame: 3 years

Death directly attributed to the primary disease

Cardiac arrest

Time Frame: 3 years

Documented ventricular fibrillation or sustained ventricular tachycardia

All cause mortality

Time Frame: 3 years

Death by any cause

Secondary Outcomes

  • Atrial fibrillation(3 years)

Study Sites (1)

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