Clinical trial NCT04112511: Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy
Official title: Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

-Patients with diagnosed hypertrophic cardiomyopathy

Exclusion Criteria:

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

Primary outcomes:
measure: Cardiac arrest
timeFrame: 3 years
measure: Implantable cardioverter defibrillator therapy
timeFrame: 3 years
measure: All cause mortality
timeFrame: 3 years
measure: Cardiovascular mortality
timeFrame: 3 years
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: 3 years
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA
Study officials:
References:
citation: 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.
citation: 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.