Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy

NCT ID: NCT04402268

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 252 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2019-02-28

Brief Summary

Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. The disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (SCD) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign course. Therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (ICD) implantation.

Detailed Description

Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left ventricular myocardium and is most often caused by mutations in sarcomere genes. The structural and functional abnormalities cannot be explained by flow-limiting coronary artery disease or loading conditions. The disease affects at least 0,2% of the population worldwide and is the most common cause of sudden cardiac death (SCD) in young people and competitive athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign course. Therefore, it is of utmost importance to properly evaluate patients and identify those who would benefit from a cardioverter-defibrillator (ICD) implantation.

This study assesses the accuracy of the HCM SCD-Risk Calculator, recommended by European Society of Cardiology guidelines, in patients treated in the Ist Department of Cardiology of Poznan University of Medical Sciences from 2005 to 2018.

The study group consisted of 252 patients aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6% were men. The protocol consisted of medical history collection (including a questionnaire), physical examination and additional tests such as echocardiography with the assessment of global longitudinal strain and average strain, cardiac magnetic resonance, ambulatory ECG monitoring, control of implantable devices and exercise testing.

Conditions

Hypertrophic Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Low risk

Low risk of sudden cardiac death according to HCM Risk-SCD Calculator

Cardioverter-defibrillator

Intervention Type: DEVICE

We analyzed how many HCM patients reached an end-point of sudden cardiac death defined as adequate intervention of cardioverter-defibrillator or sudden cardiac arrest.

Intermediate risk

Intermediate risk of sudden cardiac death according to HCM Risk-SCD Calculator

Cardioverter-defibrillator

Intervention Type: DEVICE

We analyzed how many HCM patients reached an end-point of sudden cardiac death defined as adequate intervention of cardioverter-defibrillator or sudden cardiac arrest.

High risk

High risk of sudden cardiac death according to HCM Risk-SCD Calculator

Cardioverter-defibrillator

Intervention Type: DEVICE

We analyzed how many HCM patients reached an end-point of sudden cardiac death defined as adequate intervention of cardioverter-defibrillator or sudden cardiac arrest.

Interventions

Cardioverter-defibrillator

We analyzed how many HCM patients reached an end-point of sudden cardiac death defined as adequate intervention of cardioverter-defibrillator or sudden cardiac arrest.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Hypertrophic cardiomyopathy,

2. Minimum 18 years,

3. Questionnaire,

4. Assessment of HCM SCD-Risk Calculator at the beginning of the observation,

5. Regular visits in Cardiology Outpatient Clinic,

6. Agreement to participate in the study

Exclusion Criteria

1. Poorly controlled hypertension (systolic pressure on the next two visits in the Cardiology Outpatient Clinic >180 mmHg),

2. Haemodynamically significant valvular heart disease or valve replacement condition,

3. Past myocardial infarction (haemodynamically significant changes found in coronarography),

4. Heart transplant,

5. Insufficient amount of data from the subject and additional tests allowing for further analysis,

6. Lack of consent to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Daria Adamczak

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Poznan Univeristy of Medical Sciences

Poznan, Wielkopolska, Poland

Countries

Poland

Other Identifiers

PoznanUMP

Identifier Type: -

Identifier Source: org_study_id