Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

NCT04112511 | Completed

• 1 other identifier: 4045PHD
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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. 5.Is there a correlation between myocardial deformation parameters of the left heart chambers and risk factors for sudden death?

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Atrial fibrillation

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with diagnosed hypertrophic cardiomyopathy

You may not qualify if:

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

Sponsors & Collaborators

• AHEPA University Hospital: lead

Study Sites (1)

AHEPA

Thessaloniki, Greece

Location

Related Publications (2)

• 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.

  PMID: 29045290 BACKGROUND

• 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.

  PMID: 33818698 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Resident in Cardiology

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: March 1, 2015
• Primary Completion: December 12, 2021
• Study Completion: May 5, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)