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?

Study Overview

• Status: Completed
• Conditions: Hypertrophic Cardiomyopathy

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 Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece
    • AHEPA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include all patients with diagnosed hypertrophic cardiomyopathy that will proceed for assessment in AHEPA University Hospital. Only patients with severe valvular heart disease or prior myocardial infarction will be excluded

Description

Inclusion Criteria:

-Patients with diagnosed hypertrophic cardiomyopathy

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	Documented atrial fibrillation in patients with prior sinus rythm	3 years

Collaborators and Investigators

• Sponsor: AHEPA University Hospital

Publications and helpful links

General Publications

• Zegkos T, Parcharidou D, Ntelios D, Efthimiadis G, Karvounis H. The Prognostic Implications of Two-Dimensional Speckle Tracking Echocardiography in Hypertrophic Cardiomyopathy: Current and Future Perspectives. Cardiol Rev. 2018 May/Jun;26(3):130-136. doi: 10.1097/CRD.0000000000000172.
• Zegkos T, Ntelios D, Parcharidou D, Katranas S, Panagiotidis T, Papanastasiou CA, Karagiannidis E, Rouskas P, Vassilikos V, Karvounis H, Efthimiadis GK. The predictive value of left ventricular and left atrial mechanics for atrial fibrillation and heart failure in hypertrophic cardiomyopathy: a prospective cohort study. Int J Cardiovasc Imaging. 2021 Sep;37(9):2679-2690. doi: 10.1007/s10554-021-02232-0. Epub 2021 Apr 5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2015
• Primary Completion (ACTUAL): December 12, 2021
• Study Completion (ACTUAL): May 5, 2022

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 4045PHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No