Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112511
• Other study ID #: 4045PHD
• Status: Completed
• Start date: March 1, 2015
• Est. completion date: May 5, 2022

Study information

• Verified date: July 2022
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 5, 2022
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-Patients with diagnosed hypertrophic cardiomyopathy

Exclusion Criteria:

• Concomitant severe valvular heart disease

• Prior myocardial infarction

• History of atrial fibrillation

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
Greece	AHEPA	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AHEPA University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac arrest	Documented ventricular fibrillation or sustained ventricular tachycardia	3 years
Primary	Implantable cardioverter defibrillator therapy	Aproppriate Implantable cardioverter defibrillator therapy	3 years
Primary	All cause mortality	Death by any cause	3 years
Primary	Cardiovascular mortality	Death directly attributed to the primary disease	3 years
Secondary	Atrial fibrillation	Documented atrial fibrillation in patients with prior sinus rythm	3 years