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

NCT04402268 | Completed

• 1 other identifier: PoznanUMP
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

sudden cardiac death; risk assesment; HCM Risk-SCD Calculator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• New risk factors of sudden cardiac death (SCD)

  2005-2018

Study Arms (3)

Low risk

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

Device: Cardioverter-defibrillator

Intermediate risk

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

Device: Cardioverter-defibrillator

High risk

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

Device: Cardioverter-defibrillator

Interventions

Cardioverter-defibrillator 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; Intermediate risk; Low risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Hypertrophic cardiomyopathy,
• Minimum 18 years,
• Questionnaire,
• Assessment of HCM SCD-Risk Calculator at the beginning of the observation,
• Regular visits in Cardiology Outpatient Clinic,
• Agreement to participate in the study

You may not qualify if:

• Poorly controlled hypertension (systolic pressure on the next two visits in the Cardiology Outpatient Clinic \>180 mmHg),
• Haemodynamically significant valvular heart disease or valve replacement condition,
• Past myocardial infarction (haemodynamically significant changes found in coronarography),
• Heart transplant,
• Insufficient amount of data from the subject and additional tests allowing for further analysis,
• Lack of consent to participate in the study.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan Univeristy of Medical Sciences

Poznan, Wielkopolska, 61-848, Poland

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: October 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: February 28, 2019
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)