To investigate the relation between characteristics of valve prosthesis on functional outcome andquality of life in adult patients with CHD. To investigate the prevalence and predictors of PPM in a population withCHD. To investigate the incidence of…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes are VO2max and quality of life.
Secondary outcome
Secondary outcomes are the prevalence of PPM and the incidence of valve related
complications.
Background summary
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.
Study objective
To investigate the relation between characteristics of valve prosthesis on
functional outcome and
quality of life in adult patients with CHD.
To investigate the prevalence and predictors of PPM in a population with
CHD.
To investigate the incidence of valve prosthesis-related complications in a
population with CHD
(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
Patient files of CHD patients with prosthetic valves identified from the CONCOR
database will be studied for past
medical history including surgical procedures and for the occurrence of
valve-related complications. The
cross-sectional evaluation comprises history, physical examination, VO2max,
quality of life questionnaires,
echocardiogram including prosthetic valve area, MRI (ventricular volumes and
mass), laboratory evaluation
(including NT-pro-BNP).
Study burden and risks
As all investigations are routine investigations in this population, no risk is
involved. Investigations will be scheduled as much as possible combine with an
already scheduled visit. maximum extra time for each patients is one day.
Patients may indirectly benefit from the study resulsts, because our results
may influence the choice of valve prosthesis, the indication for more extensive
surgery (e.g. annulus enlargement) and the indication for re-operation in
patients with prosthesis-patient-mismatch.
PB 30.001
9700 RB Groningen
NL
PB 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Included in concor database, congenital heart disease, valve prosthesis 9all required)
Exclusion criteria
Inability to comply with examinations (quality of life questionnaire and exercise test)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 6723 |
CCMO | NL29965.042.09 |