Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112511
Recruitment Status : Active, not recruiting
First Posted : October 2, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Zegkos, AHEPA University Hospital

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?

Condition or disease
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy
Actual Study Start Date : March 1, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021





Primary Outcome Measures :
  1. Cardiac arrest [ Time Frame: 3 years ]
    Documented ventricular fibrillation or sustained ventricular tachycardia

  2. Implantable cardioverter defibrillator therapy [ Time Frame: 3 years ]
    Aproppriate Implantable cardioverter defibrillator therapy

  3. All cause mortality [ Time Frame: 3 years ]
    Death by any cause

  4. Cardiovascular mortality [ Time Frame: 3 years ]
    Death directly attributed to the primary disease


Secondary Outcome Measures :
  1. Atrial fibrillation [ Time Frame: 3 years ]
    Documented atrial fibrillation in patients with prior sinus rythm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

-Patients with diagnosed hypertrophic cardiomyopathy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112511


Locations
Layout table for location information
Greece
AHEPA
Thessaloniki, Greece
Sponsors and Collaborators
AHEPA University Hospital
Publications:
Layout table for additonal information
Responsible Party: Thomas Zegkos, Medical Doctor, Resident in Cardiology, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT04112511    
Other Study ID Numbers: 4045PHD
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases