Clinical trial NCT02258724: Swiss National Registry of Grown up Congenital Heart Disease Patients
Official title: Swiss National Registry of Grown up Congenital Heart Disease (GUCH) Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Congenital Heart Defect
Keywords: Adult
Registry
Grown-up congenital heart disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GUCH patient treated in one of the Swiss centre with specialized organisation GUCH (University Hospital Basel, University Hospital Zurich, University Hospital Lausanne, University Hospital Geneva, Canton Hospital StGallen).

Brief summary: Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the children with congenital heart disease reach adult age.This results in an increasing number of adults or "grown-ups" with congenital heart disease (ACHD or GUCH patients) that require special health care organization and training programmes. Long term complications of these GUCH patients and optimum treatment strategies are still poorly known. The aim of this registry is to collect quantitative and qualitative data regarding GUCH patients treated in specialised centres in Switzerland.

Detailed description: The SWISS GUCH registry will capture epidemiologic data, diagnosis, type of earlier treatment / intervention and cardiac complications. Following each visit, the cardiac complications will be captured as well as the mortality.

Every GUCH patient coming for a visit in one of the specialized organisation participating to the registry will be asked to participate. After signing the informed consent form, the patient data will be coded and captured in a web-based data base (secuTrial®).

Pooling the data from the different centres will enable a nation wide register to be established. More robust data on the size and composition of the GUCH population will be obtained. Also long term prognosis of specific patient group will be derived.

Eligibility criteria: Inclusion Criteria:

Adult (above 18 years of age) with congenital heart disease, treated in one of the Swiss centre with specialized organisation for GUCH patients.

Signed informed consent. Patients with trisomy 21: the parents or legal guardian will have to give the consent.

Exclusion Criteria:

None

Primary outcomes:
measure: Mortality
timeFrame: 1 year and yearly up to 20 years
Secondary outcomes:
measure: Cardial complications
timeFrame: 1 year and yearly up to 20 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Basel University Hospital
city: Bern
country: Switzerland
facility: Bern University Hospital Inselspital
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève HUG
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois CHUV
city: St Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Daniel Tobler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moons P, Bovijn L, Budts W, Belmans A, Gewillig M. Temporal trends in survival to adulthood among patients born with congenital heart disease from 1970 to 1992 in Belgium. Circulation. 2010 Nov 30;122(22):2264-72. doi: 10.1161/CIRCULATIONAHA.110.946343. Epub 2010 Nov 22.
citation: Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.
citation: van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.
citation: Arslani K, Roffler N, Zurek M, Greutmann M, Schwerzmann M, Bouchardy J, Rutz T, Ehl NF, Jost CA, Tobler D; SACHER Investigators. Patterns of Incidence Rates of Cardiac Complications in Patients With Congenital Heart Disease. Can J Cardiol. 2018 Dec;34(12):1624-1630. doi: 10.1016/j.cjca.2018.09.010. Epub 2018 Sep 29.