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Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04112511
Enrollment
250
Registered
2019-10-02
Start date
2015-03-01
Completion date
2022-05-05
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

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.

Interventions

None listed

Sponsors

AHEPA University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

-Patients with diagnosed hypertrophic cardiomyopathy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac arrest3 yearsDocumented ventricular fibrillation or sustained ventricular tachycardia
Implantable cardioverter defibrillator therapy3 yearsAproppriate Implantable cardioverter defibrillator therapy
All cause mortality3 yearsDeath by any cause
Cardiovascular mortality3 yearsDeath directly attributed to the primary disease

Secondary

MeasureTime frameDescription
Atrial fibrillation3 yearsDocumented atrial fibrillation in patients with prior sinus rythm

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026