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Functional outcome and quality of life in adult congenital heart disease patients with prosthetic valves (PROSTAVA-study).


- candidate number6723
- NTR NumberNTR2112
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2009
- Secondary IDs 
- Public TitleFunctional outcome and quality of life in adult congenital heart disease patients with prosthetic valves (PROSTAVA-study).
- Scientific TitleFunctional outcome and quality of life in adult congenital heart disease patients with prosthetic valves (PROSTAVA-study).
- ACRONYMPROSTAVA
- hypothesis1. Prosthetic valve characteristics (type; location; size resulting in the presence/absence of PPM) are related to functional outcome and quality of life;
2. The incidence/spectrum of prosthetic valve-related complications in adults with CHD differs from populations with acquired valve disease.
- Healt Condition(s) or Problem(s) studiedAdult congenital heart disease, prosthetic valves
- Inclusion criteriaAdult Congenital Heart Disease patients with a prosthetic heart valve (both homografts, heterografts and mechanical valves in aortic, mitral, pulmonary or tricuspid position) who are included in the CONCOR database and who give informed consent for the study.
- Exclusion criteriaInability to comply with primary endpoint measures (completion of quality of life questionary, VO2max). Pregnant patients will not be included, they may be included > 3 months after pregnancy.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2010
- planned closingdate1-mrt-2013
- Target number of participants600
- InterventionsN/A
- Primary outcome1. VO2 max;
2. Quality of life.
- Secondary outcomeProsthetic valve related compliations.
- TimepointsCross sectional evaluation.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator University Medical Center Groningen (UMCG), Interuniversity Cardiology Institute of the Netherlands (ICIN), Netherlands Heart Foundation
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting)
- PublicationsN/A
- Brief summaryBackground:
In patients with congenital heart disease (CHD), often mechanical or biological prosthetic valves are implanted. These patients differ from adults who have prosthetic valves implanted for acquired valve disease (e.g. differences in age, lifestyle, variety of valve location). The prevalence of pulmonary and tricuspid prosthetic valves is high. The prevalence of prosthesis-patient-mismatch (PPM) is probably high because often valves were implanted during childhood. In patients with acquired valve disease PPM is associated with decreased survival and increased incidence of heart failure. Data about the prevalence of PPM in adults with CHD are lacking. The probable high prevalence of PPM and the complicated history of many CHD patients may predestinate them for complications such as heart failure and arrhythmias. The influence of prosthetic valve characteristics (type, location, size/PPM) in adults with CHD on functional outcome and quality of life has however not been investigated. Moreover, data about the long-term complications of prosthetic valves in adults with CHD are scarce. For example, in the pulmonary position usually biological valves are implanted because of a presumed high incidence of thrombo-embolism associated with mechanical valves, but scientific evidence confirming this presumption is lacking.

Hypothesis:
1. Prosthetic valve characteristics (type; location; size resulting in the presence/absence of PPM) are related to functional outcome and quality of life;
2. The incidence/spectrum of prosthetic valve-related complications in adults with CHD differs from populations with acquired valve disease.

Objective:
Main objective: To investigate the relation between characteristics of valve prosthesis on functional outcome and quality of life in adult patients with CHD.
Secondary objectives: To investigate the prevalence and determine predictors of PPM in an adult population with CHD. To retrospectively investigate the prevalence of valve prosthesis-related complications in an adult population with CHD and a valve prosthesis (re-operation, valve thrombosis, bleeding complications, hemolysis, paravalvular regurgitation, endocarditis, arrhythmias, pregnancy-related complications, heart failure). To investigate the relation between prosthesis related complications and valve type.

Study design:
Multi-centre cross sectional observational study.

Study population:
Patients with valve prostheses identified from the CONCOR national database for adult congenital heart disease .

Main study parameters/endpoints:
Primary outcome measures: VO2max and quality of life. Secondary outcome measures: prevalence of prosthesis-patient mismatch, incidence of prosthetic valve-related complications.
- Main changes (audit trail)
- RECORD17-nov-2009 - 29-nov-2009


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