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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Cardiomyopathy
• Intervention / Treatment: Device: Cardioverter-defibrillator

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.

• Study Type: Observational
• Enrollment (Actual): 252

Contacts and Locations

Study Locations

• Poland
  • Wielkopolska
    • Poznań, Wielkopolska, Poland, 61-848
      • Poznan Univeristy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study group consisted of 252 patients with hypertrophic cardiomyopathy aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6% were men.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low risk; Low risk of sudden cardiac death according to HCM Risk-SCD Calculator	Device: 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.
Intermediate risk; Intermediate risk of sudden cardiac death according to HCM Risk-SCD Calculator	Device: 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.
High risk; High risk of sudden cardiac death according to HCM Risk-SCD Calculator	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sudden cardiac death (SCD) in risk groups	Number of SCD cases in each of risk groups according to HCM Risk-SCD Calculator	2005-2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New risk factors of sudden cardiac death (SCD)	New echocardiographic features, such as glibal longitudinal strain, average strain, left atrial volume index, which allow to better estimate the risk of SCD	2005-2018

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: sudden cardiac death; risk assesment; HCM Risk-SCD Calculator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Death, Sudden; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Heart Arrest; Death; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Death, Sudden, Cardiac
• Other Study ID Numbers: PoznanUMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not possible due to Polish law regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No