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Early diagnosis of right ventricular dysfunction in patients operated for tetralogy of Fallot. A multicentre study with serial follow-up.

Early diagnosis of right ventricular dysfunction in patients operated for tetralogy of Fallot. A multicentre study with serial follow-up. - Heartfailure in patients operated for tetralogy of Fallot

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30617
Enrollment
120
Registered
2007-02-14
Start date
2007-09-28
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tetralogy of Fallot

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)