Fontan circulation: Analysis of its Impact on quality of life and Rate of deterioration (FAIR study)

Fontan circulation: Analysis of its Impact on quality of life and Rate of deterioration (FAIR study) - Predictors of Fontan attrition.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37862

Enrollment

100

Registered

2012-06-13

Start date

2012-07-02

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Fontan total cavopulmonary connection

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients who underwent a Fontan/TCPC procedure - follow-up at UMCG - age: 10 years or older

Exclusion criteria

Exclusion criteria: No overall exclusion criteria. For the individual investigations there may be separate exclusion criteria (e.g. Pacemaker is an exclusion criterion for MRI investigation).

Design outcomes

Primary

Measure	Time frame
Decrease of the exercise tolerance.	—

Secondary

Measure	Time frame
Decrease in NYHA class Mortality Quality of life Laboratorium measurements: NTproBNP, haemoglobin level, creatinin, endothelin-1, coagulation tests, albumin, ASAT, ALAT, γGT, creatinin. Echocardiography: systolic, diastolic and valve function. Magnetic Resonance Imaging: ventricular ejection fraction, pulmonary flow patterns, hepatic flow patterns, portal hypertension, liver cirrhosis. Holter monitoring/ECG: Arrhythmias. Spirometry: FVC, FEV1	—

Measure

Time frame

Decrease in NYHA class Mortality Quality of life Laboratorium measurements: NTproBNP, haemoglobin level, creatinin, endothelin-1, coagulation tests, albumin, ASAT, ALAT, γGT, creatinin. Echocardiography: systolic, diastolic and valve function. Magnetic Resonance Imaging: ventricular ejection fraction, pulmonary flow patterns, hepatic flow patterns, portal hypertension, liver cirrhosis. Holter monitoring/ECG: Arrhythmias. Spirometry: FVC, FEV1

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Countries

Netherlands

Outcome results