The role of the pulmonary vasculature in the Fontan circulatio

Completed

• Conditions: Fontan; 10010394; 10007510; 10037454; Total cavopulmonary connection

• Registration Number: NL-OMON44674
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Fontan group:
- written informed consent
- Patients who underwent a TCPC/Fontan procedure
- Follow-up at UMCG
- adult 18 years or older
- Clinical indication for cardiac catheterization;Control group:
- written informed consent
- absence of Fontan circulation or univentricular heart-like diagnosis
- Follow-up at UMCG
- adult 18 years or older
- clinical indication for right heart catheterization
- absence of pulmonary vascular diseases
- normal pulmonary vascular hemodynamic profile;PAH group
- Written informed consent
- Clinical indication for right heart catheterization
- History of pulmonary arterial hypertension [PAH] diagnosis (criteria; mean pulmonary artery pressure > 25mmHg, pulmonary capillary wedge pressure <15mmHg, pulmonary vascular resistance index > 3 wood units, and other possible causes for pulmonary hypertension excluded).
- Reconfirmation of PAH diagnosis based on hemodynamic criteria during the right heart catheterization.

Exclusion Criteria

Fontan group:
- Standard exclusion criteria for cardiac catheterization
- Obstruction in Fontan conduit
- Inability to measure a reliable cardiac index and PVR (rhythm instability, hemodynamic or anatomic reasons);Control group:
- No specific exclusion criteria apart from the standard exclusion criteria for right heart catheterization;PAH group
- No specific exclusion criteria apart from the standard exclusion criteria for right heart catheterization.
- Inability to perform a pulmonary OCT measurement during right catheterization (rhythm instability, hemodynamic or anatomic reasons)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>- Change in indexed cardiac output (l/min/m2) between condition 2 and condition<br /><br>3<br /><br>- Presence of intimal lesions in the small pulmonary arteries</p><br>