In patients who have undergone surgical repair of TOF, we aim to- assess the development of RV dimensions and function in relation to clinical outcome, in a time dependent manner,- identify, chracterize and quantify markers in blood samples, using…
ID
Source
Brief title
Condition
- Heart failures
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome measures are differences between baseline (already available) and
current (to be obtained in this project):
1) RV end-systolic volume
2) RV ejection fraction
3) NYHA functional class
4) maximal oxygen uptake
5) maximal workload
6) biomarkers
Secondary outcome
Identify, chracterize and quantify markers in blood samples, using high density
antibody arrays and ELISAs, obtained from Fallot patients at different stages
of development of RV overload and hypertrophy,
Correlate circulating levels of identified markers with cardiac an systemic
parameters, and to identify (a) potential biomarker(s) as a diagnostic and
prognostic tool(s)
Background summary
Tetralogy of Fallot (TOF) is the most common type of cyanotic congenital heart
disease. After surgical repair, residual pulmonary regurgitation (PR) is
common. Long-term quality of life is limited by the effects of PR which include
an increased risk of heart failure from right ventricular(RV) dilatation. The
course of development towards pathological RV dilatation has been poorly
characterised. Risk factors are not well defined, myocardial remodelling
pathways in RV overload have hardly been studied in patients, and indices
predictive of RV dysfunction are lacking. This hampers clinical dicision
making. In LV disease, neurohormonal and inflammatory markers have contributed
to risk stratification in patients. Recently, high desity protein arrays have
been helpful to identify biomarkers of ventricular remodelling.
Study objective
In patients who have undergone surgical repair of TOF, we aim to
- assess the development of RV dimensions and function in relation to clinical
outcome, in a time dependent manner,
- identify, chracterize and quantify markers in blood samples, using high
density antibody arrays and ELISAs, obtained from Fallot patients at different
stages of development of RV overload and hypertrophy,
- correlate circulating levels of identified markers with cardiac an systemic
parameters, and to identify (a) potential biomarker(s) as a diagnostic and
prognostic tool(s)
Study design
This study is a prospective, patient-base study
Study burden and risks
Study participants operated on tetralogy of Fallot will undergo the same
protocol as patients not included in this studyprotocol. There will be no
difference in treatment.
In this study participants who have already participated in an earlier
Fallot-study in contributing centres will be approached by their cardiac
specialist to participate in this study on the condition they have been
participating in a Fallot study at least 5 years ago and meet all the in- and
exclussion criteria. The exsisting data of former studies will be the baseline
value of this study.
All participants will be invited to the outpatient clinic in the participating
centres to collect studydata. All data will be gathered in 1 day . If this is
to much a burden for the patient we will collect the data in 2 days. Outcome
measures in this study: difference between current and baseline:1) RV
end0systolic volume (ml/m2 BSA) 2) RV ejection fraction 3) NYHA functional
class 4) maximal oxygen uptake (adjusted for age, gender and weight) 5) maximal
work load (adjusted for age, gender and weight) 6) biomarkers.
Participating in this study will not be of any additional burden or risk to
participants, compared to regular clinical follow-up.
Postbus 2060
3000 CB Rotterdam
NL
Postbus 2060
3000 CB Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Diagnosis: Tetralogy of Fallot. Only patients that previously had systematic evaluation of medical history, clinical status, MRI, ECG, excercise performance and biomarkers of ventricular remodeling.
Exclusion criteria
Diagnosis of major systemic-pulmonary collateral arteries
Residual pulmonary stenosis with a gradient of > 40 mm Hg (Doppler)
Residual VSD, aortic stenosis and/or regurgitation
Residual arterial desaturation
Complete repair with homograft
Absent pulmonary valve Syndrome
Mental retardation
Pulmonary valve replacement secondary to tetralogy correction
Contra-indications to MRI
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 |
|---|---|
| CCMO | NL15007.078.06 |