NCT03957824: PREVENTIONACHD

PREVENTION-ACHD Risk Score

Completed Last updated 21 May 2019

What this trial tests

trial testing PREVENTION-ACHD risk score in Death, Sudden, Cardiac in 783 participants. Completed in 30 June 2018.

Timeline

1 January 2015

Primary endpoint
31 December 2015

30 June 2018

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	783
Start date	1 January 2015
Primary completion	31 December 2015
Estimated completion	30 June 2018

Drugs / interventions tested

• PREVENTION-ACHD risk score

Conditions studied

• Death, Sudden, Cardiac — all drugs for Death, Sudden, Cardiac →
• Ventricular Fibrillation — all drugs for Ventricular Fibrillation →
• Ventricular Tachycardia — all drugs for Ventricular Tachycardia →
• Congenital Heart Disease — all drugs for Congenital Heart Disease →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

18 and older, any sex, with Death, Sudden, Cardiac or Ventricular Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. PREVENTION-ACHD: PRospEctiVE study on implaNTable cardioverter-defibrillator therapy and suddeN cardiac death in Adults with Congenital Heart Disease; Rationale and Design.
   Vehmeijer JT, Koyak Z, Zwinderman AH, Harris L, et al · · 2019 · cited 14× · PMID 31270738 · DOI 10.1007/s12471-019-1297-3