NCT02258724

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Sep 2013Dec 2033

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
19.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2033

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

20.3 years

First QC Date

September 24, 2014

Last Update Submit

April 28, 2026

Conditions

Congenital Heart DiseaseCongenital Heart Defect

Keywords

AdultRegistryGrown-up congenital heart disease

Outcome Measures

Primary Outcomes (1)

  • Mortality

    1 year and yearly up to 20 years

Secondary Outcomes (1)

  • Cardial complications

    1 year and yearly up to 20 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Basel University Hospital

Basel, 4031, Switzerland

RECRUITING

Bern University Hospital Inselspital

Bern, 3010, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève HUG

Geneva, 1205, Switzerland

RECRUITING

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, 1011, Switzerland

RECRUITING

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21098444BACKGROUND

  • 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.

    PMID: 12084585BACKGROUND

  • 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.

    PMID: 22078432BACKGROUND

  • 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.

    PMID: 30527151DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Daniel Tobler, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Tobler, MD

CONTACT

+41 61 265 52 14daniel.tobler@usb.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 7, 2014

Study Start

September 1, 2013

Primary Completion (Estimated)

December 1, 2033

Study Completion (Estimated)

December 1, 2033

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

CH(6)