Exploring the pulmonary blood vessels in Fontan patients
The Role of the Pulmonary Vasculature in the Fontan Circulation
University Medical Center Groningen · NCT02414321
This study looks at the blood vessels in adults who had the Fontan surgery for heart defects to see how they work during exercise and how this might help improve treatments for these patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Locations | 1 site (Groningen) |
| Trial ID | NCT02414321 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the structural and functional characteristics of the pulmonary vasculature in adults who have undergone the Fontan operation for congenital heart disease. It aims to determine how pulmonary vasodilatation affects cardiac output during simulated exercise and to characterize the structural properties of small pulmonary arteries. The study utilizes advanced imaging techniques like Optical Coherence Tomography and pulmonary vascular response tests to gather data during clinically indicated cardiac catheterizations. The findings may highlight the pulmonary circulation as a potential target for future treatments to improve outcomes for Fontan patients.
Who should consider this trial
Good fit: Ideal candidates include adults who have undergone the Fontan operation and have a clinical indication for cardiac catheterization.
Not a fit: Patients with significant pulmonary vascular disease or those who cannot undergo reliable cardiac index and PVR measurements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies that improve long-term outcomes for patients with Fontan circulation.
How similar studies have performed: While studies on pulmonary vascular resistance in Fontan patients exist, this specific approach using advanced imaging and vasodilators is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: Fontan group * written informed consent * Clinical indication for cardiac catheterization Control group * written informed consent * Clinical indication for right heart catheterization * Absence of pulmonary vascular disease * Normal pulmonary vascular hemodynamic profile 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.
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Rolf M Berger, MD PhD — University Medical Center Groningen
- Study coordinator: Floris-Jan S Ridderbos, MD
- Email: f.j.s.ridderbos@umcg.nl
- Phone: +31503611506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease, Fontan Operation, Pulmonary Vascular Resistance, Pulmonary Vascular Remodeling