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

• Conditions: single ventricle; Univentricular heart; 10010394; 10007510; 10007593

• Registration Number: NL-OMON46653
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 90

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

Claustrophobia
Contraindication for MRI
<8 years old
Pacemaker in situ

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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