PREVENTION-ACHD Risk Score

Sudden cardiac death (SCD) is one of the major causes of mortality in adults with congenital heart disease (ACHD). Risk stratification for sudden cardiac death in this patient group is challenging and at the current moment there are no clear guidelines on implantable cardioverter-defibrillator (ICD) implantation for primary prevention of SCD in this young patient population. The reason for this is the fact that this is a heterogenous group of patients and SCD is a relatively rare event. Because of this there have been no prospective studies on SCD in ACHD. However, multiple retrospective studies on ICD implantation in ACHD have shown that this treatment does appear to be effective. Researchers from the Academic Medical Center have identified several risk factors for sudden cardiac death. A risk score was created using this data, which has been validated in an internal and external cohort in a retrospective setting. The design of this study, including the conception of the risk score, its calculation method and validation will be published in an international scientific peer-reviewed journal.

The hypothesis of this study is that the risk score accurately predicts the risk of sudden cardiac death.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Death, Sudden, Cardiac Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Death, Sudden Heart Arrest Heart Defects, Congenital Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adult (≥18 years old) patient with a diagnosis of a congenital heart defect.

Exclusion criteria

Patients of whom follow up is not possible, e.g. no permanent home address, living outside of or expecting to move out of the area wherein travelling to the investigating hospital outpatient clinic is possible.

Patients with documented sustained ventricular tachycardia or ventricular fibrillation.
Patients for whom the risk is not calculable because of a congenital heart disease diagnose not represented in the risk score.
Patients for whom the risk score is not calculable because of missing data
Patients with recent (<3 months ago) myocardial infarction.
Patients in whom the high SCD-risk status depends on an impaired ejection fraction that is expected to improve, e.g. due to tachycardiomyopathy.
Patients with a guideline defined contraindication for ICD implantation.

Treatment and study plan

PREVENTION-ACHD risk score

Diagnostic Test

The predicted risk of sudden cardiac death according to a risk score will be tested by the actual rate of sudden cardiac death

Primary outcomes

Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia

Time frame: 2 years

The rate of sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia in adult congenital heart disease patients

Secondary outcomes

Sudden cardiac death

Time frame: 2 years

The rate of sudden cardiac death in adult congenital heart disease patients

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

PRospEctiVE Study on implaNTable cardIOverter Defibrillator Therapy and SuddeN Cardiac Death in Adults With Congenital Heart Defects

Acronym: PREVENTIONACHD

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2018
First posted: May 21, 2019
Registry last updated: May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed