Fontan-velocity study: Four-dimensional blood flow MRI analysis in patients with a Fontan circulation

Fontan-velocity study: Four-dimensional blood flow MRI analysis in patients with a Fontan circulation - Fontan-Velocity study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46653

Enrollment

Registered

2018-08-20

Start date

2018-03-01

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

single ventricle Univentricular heart

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with an intact Fontan-TCPC circulation performed at the LUMC >8years of age No contra-indications for exercise test No contra-indications for MRI examination

Exclusion criteria

Exclusion criteria: Claustrophobia Contraindication for MRI

Design outcomes

Primary

Measure	Time frame
Echocardiographic parameters: Cardiac index MRI parameters: Cardiac and Fontan tunnel: Flow patterns and Energetics (energy loss) Liver: Liver Multi-scan (fat, iron, fibrosis level) Exercise test parameters: peak oxygen uptake (VO2 max) Stool parameter: alpha-1 antitrypsin Clinical parameters: NYHA class Episodes of PLE in history Holter: Arrythmias	—

Secondary

Measure	Time frame
Echocardiographic parameters: ejection fraction, grading of AVV regurgitation, E/A ratio, propagation velocity MRI parameters: Cardiac: End diastolic volume (EDV), End systolic volume (ESV), single ventricle ejection fraction (EF), quantification of AVV regurgitation Cardiac and Fontan tunnel: Energetics (kinetic energy, turbulent kinetic energy, vorticity, wall shear stress) Exercise test parameters: Peak heart rate, percentage of expected Watts. Blood parameters: complete blood count liver function kidney function albumin and total protein NT-proBNP, hs-TnT, GDF-15 Urine parameter: Protein Clinical parameters: Time from Fontan operation	—

Measure

Time frame

Echocardiographic parameters: ejection fraction, grading of AVV regurgitation, E/A ratio, propagation velocity MRI parameters: Cardiac: End diastolic volume (EDV), End systolic volume (ESV), single ventricle ejection fraction (EF), quantification of AVV regurgitation Cardiac and Fontan tunnel: Energetics (kinetic energy, turbulent kinetic energy, vorticity, wall shear stress) Exercise test parameters: Peak heart rate, percentage of expected Watts. Blood parameters: complete blood count liver function kidney function albumin and total protein NT-proBNP, hs-TnT, GDF-15 Urine parameter: Protein Clinical parameters: Time from Fontan operation

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Countries

Netherlands

Outcome results