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Completed

NCT Number: NCT04112511

Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

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?

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

AHEPA

Thessaloniki, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Patients with diagnosed hypertrophic cardiomyopathy

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Cardiac arrest

    Time frame: 3 years

    Documented ventricular fibrillation or sustained ventricular tachycardia

  2. Implantable cardioverter defibrillator therapy

    Time frame: 3 years

    Aproppriate Implantable cardioverter defibrillator therapy

  3. All cause mortality

    Time frame: 3 years

    Death by any cause

  4. Cardiovascular mortality

    Time frame: 3 years

    Death directly attributed to the primary disease

Secondary outcomes

  1. Atrial fibrillation

    Time frame: 3 years

    Documented atrial fibrillation in patients with prior sinus rythm

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Oct 2, 2019
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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