- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258724
Swiss National Registry of Grown up Congenital Heart Disease Patients (GUCH)
Swiss National Registry of Grown up Congenital Heart Disease (GUCH) Patients
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Daniel Tobler, MD
- Phone Number: +41 61 265 52 14
- Email: daniel.tobler@usb.ch
Study Locations
-
-
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Basel, Switzerland, 4031
- Recruiting
- Basel University Hospital
-
Contact:
- Daniel Tobler, MD
- Phone Number: +41 61 265 52 14
- Email: daniel.tobler@usb.ch
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Bern, Switzerland, 3010
- Recruiting
- Bern University Hospital Inselspital
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Contact:
- Mathias Possner, PD. MD
- Phone Number: +41 31 632 7859
- Email: mathias.possner@insel.ch
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Contact:
- Fabienne Schwitz, MD
- Phone Number: 7679 +41 31 632 21 11
- Email: fabienne.schwitz@insel.ch
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Geneva, Switzerland, 1205
- Recruiting
- Hôpitaux Universitaires de Genève HUG
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Contact:
- Judith Bouchardy, MD
- Phone Number: +41 22 372 75 31
- Email: judith.bouchardy@hcuge.ch
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Lausanne, Switzerland, 1011
- Recruiting
- Centre Hospitalier Universitaire Vaudois CHUV
-
Contact:
- Judith Bouchardy, MD
- Phone Number: +41 79 55 65 467
- Email: judith.bouchardy@chuv.ch
-
Contact:
- Tobias Rutz, MD
- Phone Number: +41 79 55 670 33
- Email: tobias.rutz@chuv.ch
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St Gallen, Switzerland, 9007
- Recruiting
- Kantonsspital St.Gallen
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Contact:
- Dominik Stambach, MD
- Phone Number: +41 71 494 10 51
- Email: dominik.stambach@kispisg.ch
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Zurich, Switzerland, 8091
- Recruiting
- University Hospital Zurich
-
Contact:
- Matthias Greutmann, MD
- Phone Number: +41 44 255 38 83
- Email: Matthias.Greutmann@usz.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 1 year and yearly up to 20 years
|
1 year and yearly up to 20 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardial complications
Time Frame: 1 year and yearly up to 20 years
|
Requiring in-patient hospitalisation, strokes, re-intervention
|
1 year and yearly up to 20 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniel Tobler, MD, University Hospital, Basel, Switzerland
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKBB 180/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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