Early diagnosis of right ventricular dysfunction in patients operated for tetralogy of Fallot. A multicentre study with serial follow-up.
Completed
- Conditions
- 1000751010019280tetralogy of Fallot
- Registration Number
- NL-OMON30617
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Outcome measures are differences between baseline (already available) and<br /><br>current (to be obtained in this project):<br /><br>1) RV end-systolic volume<br /><br>2) RV ejection fraction<br /><br>3) NYHA functional class<br /><br>4) maximal oxygen uptake<br /><br>5) maximal workload<br /><br>6) biomarkers</p><br>
- Secondary Outcome Measures
Name Time Method <p>Identify, chracterize and quantify markers in blood samples, using high density<br /><br>antibody arrays and ELISAs, obtained from Fallot patients at different stages<br /><br>of development of RV overload and hypertrophy,<br /><br><br /><br>Correlate circulating levels of identified markers with cardiac an systemic<br /><br>parameters, and to identify (a) potential biomarker(s) as a diagnostic and<br /><br>prognostic tool(s)</p><br>