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Long term Results Congenital Cardiologic Abnormalities (LUCCA).


- candidate number5007
- NTR NumberNTR1611
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jan-2009
- Secondary IDsTHCHOZ 2008-12 
- Public TitleLong term Results Congenital Cardiologic Abnormalities (LUCCA).
- Scientific TitleLong 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.
- ACRONYMLUCCA
- hypothesisTo get insight in the long term results (mortality, morbidity and cardiologic function) of patients with congenital heart disease operated at young age. To compare whether the changes in surgical techniques have resulted in an increase of (complication free) survival and quality of life.
- Healt Condition(s) or Problem(s) studiedCongenital heart defects
- Inclusion criteriaThe 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 criteriaNon compos mentis, mentally disabled persons.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate1-dec-2010
- Target number of participants280
- InterventionsThis study is a clinical longitudinal cohort study. Interventions: ECG 12 lead, 24 hour holter, bicycle exertion test, TTE, Physical examination, Psychological investigation, MRI.
- Primary outcomeMortality, morbidity (defined as re-operation, re-intervention, pacemaker implantation, arrhythmias and cardiac failure).
- Secondary outcomeHeart function of the left and right ventricle, exercise capacity and quality of life.
- TimepointsOne visit, circa 19-29 year after the first operation.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMw. P.T.E. Ruys
- CONTACT for SCIENTIFIC QUERIESDr. J.W. Roos-Hesselink
- Sponsor/Initiator Erasmus Medical Center, Department of Cardiology and Radiology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Cardiology
- Publications
- Brief summaryBackground:
A congenital cardiologic abnormality is encountered 8 per 1000 live births. In the present era the 20 years survival of patients born with a congenital heart defect is 85 percent or more. Since 1968 surgical correction of these defects can be preformed in Rotterdam using a hart-long machine. Complications and residual lesions seen after the operation of congenital heart abnormalities are valve dysfunction, arrhythmias, endocarditis and heart failure. By registrating these problems, there will be a better understanding of the late problems and a better insight will be gained in what topics need special attention and what is the best timing for (re-) intervention. Long-term follow-up of congenital heart disease patients is important to get insight in survival as well as quality of life. Whether with the contemporary surgical techniques and psychological help, the patients have a good quality of life, is one of the questions to be answered. In the present study we want to investigate the cohort of patients operated on between 1980 and 1990 and compare the results with a cohort study of patients operated between 1968 and 1980.

Objective:
To get insight in the long term results (mortality, morbidity and cardiologic function) of patients with congenital heart disease operated at young age. To compare whether the changes in surgical techniques have resulted in an increase of (complication free) survival and quality of life.

Design:
This study is a clinical longitudinal cohort study.

Population:
The following patient groups 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.

Primary parameters/outcome:
Primary end points are mortality, morbidity (defined as re-operation, re-intervention, pacemaker implantation, arrhythmias and cardiac failure).

Secondary parameters:
Heart function of the left and right ventricle, exercise capacity and quality of life.

Risks:
Due to the non-invasive nature of the research (ECG, holter, echocardiography and bicycle exercise test) the health risks are very low. In most cases also an MRI will be made. In very rare cases a patient is allergic to the contrast agent used at MRI. Patients will be asked whether they are allergic. Special care will be available at all time in case of an allergic reaction.
- Main changes (audit trail)
- RECORD2-jan-2009 - 8-feb-2009


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