Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02258724
Recruitment Status : Recruiting
First Posted : October 7, 2014
Last Update Posted : October 15, 2018
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease
Congenital Heart Disease Congenital Heart Defect

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Swiss National Registry of Grown up Congenital Heart Disease (GUCH) Patients
Study Start Date : September 2013
Estimated Primary Completion Date : December 2033
Estimated Study Completion Date : December 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 year and yearly up to 20 years ]

Secondary Outcome Measures :
  1. Cardial complications [ Time Frame: 1 year and yearly up to 20 years ]
    Requiring in-patient hospitalisation, strokes, re-intervention

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02258724

Layout table for location contacts
Contact: Daniel Tobler, MD +41 61 265 52 14

Layout table for location information
Basel University Hospital Recruiting
Basel, Switzerland, 4031
Contact: Daniel Tobler, MD    +41 61 265 52 14   
Bern University Hospital Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Markus Schwerzmann, Prof. MD    +41 31 632 7859   
Contact: Kerstin Wustmann, MD    +41 31 632 21 11 ext 7679   
Hôpitaux Universitaires de Genève HUG Recruiting
Geneva, Switzerland, 1205
Contact: Judith Bouchardy, MD    +41 22 372 75 31   
Centre Hospitalier Universitaire Vaudois CHUV Recruiting
Lausanne, Switzerland, 1011
Contact: Judith Bouchardy, MD    +41 79 55 65 467   
Contact: Tobias Rutz, MD    +41 79 55 670 33   
Kantonsspital St.Gallen Recruiting
St Gallen, Switzerland, 9007
Contact: Dominik Stambach, MD    +41 71 494 10 51   
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Matthias Greutmann, MD    +41 44 255 38 83   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Layout table for investigator information
Principal Investigator: Daniel Tobler, MD University Hospital, Basel, Switzerland

Additional Information:

Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT02258724     History of Changes
Other Study ID Numbers: EKBB 180/13
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Keywords provided by University Hospital, Basel, Switzerland:
Grown-up congenital heart disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities