Swiss National Registry of Grown up Congenital Heart Disease Patients

Congenital Heart Disease Clinical Trial

— GUCH  

Official title:

Swiss National Registry of Grown up Congenital Heart Disease (GUCH) Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02258724
• Other study ID #: EKBB 180/13
• Status: Recruiting
• Start date: September 2013
• Est. completion date: December 2033

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Daniel Tobler, MD
• Phone: +41 61 265 52 14
• Email: daniel.tobler[@]usb.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2033
• Est. primary completion date: December 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Defect
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
Switzerland	Basel University Hospital	Basel
Switzerland	Bern University Hospital Inselspital	Bern
Switzerland	Hôpitaux Universitaires de Genève HUG	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois CHUV	Lausanne
Switzerland	Kantonsspital St.Gallen	St Gallen
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		1 year and yearly up to 20 years
Secondary	Cardial complications	Requiring in-patient hospitalisation, strokes, re-intervention	1 year and yearly up to 20 years