Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

Completed

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT04112511
• Lead Sponsor: AHEPA University Hospital

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.

Study Timeline

• Study Start: 2015-03-01
• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Primary Completion: 2021-12-12
• Study Completion: 2022-05-05
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

-Patients with diagnosed hypertrophic cardiomyopathy

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implantable cardioverter defibrillator therapy	3 years	Aproppriate Implantable cardioverter defibrillator therapy
Cardiovascular mortality	3 years	Death directly attributed to the primary disease
Cardiac arrest	3 years	Documented ventricular fibrillation or sustained ventricular tachycardia
All cause mortality	3 years	Death by any cause

Secondary Outcome Measures

Name	Time	Method
Atrial fibrillation	3 years	Documented atrial fibrillation in patients with prior sinus rythm

Trial Locations

Locations (1)

AHEPA; 🇬🇷 Thessaloniki, Greece