|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR1611 |
|
Date of registration:
|
02/01/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Long term Results Congenital Cardiologic Abnormalities (LUCCA).
|
|
Scientific title:
|
Long term Results Congenital Cardiologic Abnormalities (LUCCA).
Cardiologic and Psychologic follow up after heartsurgery for congenital heart abnormalities of patients born with a congenital heart defect, in the period 1980 - 1990.
- LUCCA |
|
Date of first enrolment:
|
1/2/2009 |
|
Target sample size:
|
280 |
|
Recruitment status: |
recruiting |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1611 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: Single arm
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
P.T.E.
Ruys |
|
Address:
|
Erasmus MC Rotterdam
's Gravendijkwal 230, Afd. cardiologie/thoraxchirurgie
3015 CE
Rotterdam
The Netherlands |
|
Telephone:
|
+31 (0)10 7033989 |
|
Email:
|
titiaruys@hotmail.com |
|
Affiliation:
|
|
|
|
Name:
|
J.W.
Roos-Hesselink |
|
Address:
|
Erasmus Medical Center, Department of Cardiology,
P.O. Box 2040
3000 CA
Rotterdam
The Netherlands |
|
Telephone:
|
+31 (0)10 4632432 |
|
Email:
|
j.roos@erasmusmc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: The following patient group with a congenital heart disease operated on in the Erasmus MC in the period 1980 till 1990, younger then 15 at operation:
atrial septum defect (ASD), tetralogy of Fallot, transposition of the great arteries and a complex heart disease.
Exclusion criteria: Non compos mentis, mentally disabled persons.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Congenital heart defects
|
|
Intervention(s)
|
|
This study is a clinical longitudinal cohort study. Interventions: ECG 12 lead, 24 hour holter, bicycle exertion test, TTE, Physical examination, Psychological investigation, MRI.
|
|
Primary Outcome(s)
|
Mortality, morbidity (defined as re-operation, re-intervention, pacemaker implantation, arrhythmias and cardiac failure).
|
|
Secondary Outcome(s)
|
Heart function of the left and right ventricle, exercise capacity and quality of life.
|
|
Secondary ID(s)
|
|
THCHOZ 2008-12
|
|
Source(s) of Monetary Support
|
|
Erasmus Medical Center, Department of Cardiology
|
|