The Role of the Pulmonary Vasculature in the Fontan Circulation
NCT ID: NCT02414321
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2015-06-30
2024-10-30
Brief Summary
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Objectives:
* Determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise.
* Characterization of structural properties of small pulmonary arteries.
Detailed Description
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The Fontan circulation is a palliation for patients with a functionally univentricular heart. The Fontan circulation is characterized by impaired exercise capacity and gradual attrition over time. To date treatment options are extremely limited. It has been proposed that pulmonary vascular resistance (PVR) is the controlling and limiting factor of cardiac output in the Fontan circulation. Remodeling of the pulmonary vasculature and increasing PVR are possible key factors in the long term failure of the Fontan circulation. Optical Coherence Tomography (OCT) is an intravascular imaging modality used for structural characterization of blood vessels. Nitric oxide is a pulmonary vasodilator used in pulmonary vascular response tests, aimed at lowering PVR which may improve cardiac output in the Fontan circulation. These two diagnostic procedures are tools to study the structural and functional characteristics of the pulmonary vasculature in the Fontan circulation. The results of this study could identify the pulmonary circulation as a future treatment target in Fontan patients and may provide clues for new therapeutic treatment strategies to improve the long term outcome of these patients.
Study procedure:
The study protocol will be performed during a clinically indicated cardiac catheterization. In the context of this study additional measurements will be performed which will include a pulmonary vascular response test, trans-thoracic echocardiography and pulmonary artery OCT measurements.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Fontan group
Right heart catheterization:
* pulmonary artery OCT analysis
* dobutamine stress test
* pulmonary vascular response test (nitric oxide)
* trans-thoracic echocardiography
No interventions assigned to this group
Control group
Right heart catheterization:
\- pulmonary artery OCT analysis
No interventions assigned to this group
PAH group
Right heart catheterization:
\- pulmonary artery OCT analysis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Obstruction in Fontan conduit
* Inability to measure a reliable cardiac index and PVR (rhythm instability, hemodynamic or anatomic reasons)
Control Group
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Prof. dr. R.M.F. Berger
Professor and Head of Department of Pediatric Cardiology
Principal Investigators
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Rolf M Berger, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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References
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Fontan F, Baudet E. Surgical repair of tricuspid atresia. Thorax. 1971 May;26(3):240-8. doi: 10.1136/thx.26.3.240.
Wolff D, van Melle JP, Ebels T, Hillege H, van Slooten YJ, Berger RM. Trends in mortality (1975-2011) after one- and two-stage Fontan surgery, including bidirectional Glenn through Fontan completion. Eur J Cardiothorac Surg. 2014 Apr;45(4):602-9. doi: 10.1093/ejcts/ezt461. Epub 2013 Sep 25.
de Leval MR, Deanfield JE. Four decades of Fontan palliation. Nat Rev Cardiol. 2010 Sep;7(9):520-7. doi: 10.1038/nrcardio.2010.99. Epub 2010 Jun 29.
Gewillig M, Brown SC, Eyskens B, Heying R, Ganame J, Budts W, La Gerche A, Gorenflo M. The Fontan circulation: who controls cardiac output? Interact Cardiovasc Thorac Surg. 2010 Mar;10(3):428-33. doi: 10.1510/icvts.2009.218594. Epub 2009 Dec 7.
Goldberg DJ, Avitabile CM, McBride MG, Paridon SM. Exercise capacity in the Fontan circulation. Cardiol Young. 2013 Dec;23(6):824-30. doi: 10.1017/S1047951113001649.
Khambadkone S, Li J, de Leval MR, Cullen S, Deanfield JE, Redington AN. Basal pulmonary vascular resistance and nitric oxide responsiveness late after Fontan-type operation. Circulation. 2003 Jul 1;107(25):3204-8. doi: 10.1161/01.CIR.0000074210.49434.40. Epub 2003 Jun 23.
Ridderbos FJ, Wolff D, Timmer A, van Melle JP, Ebels T, Dickinson MG, Timens W, Berger RM. Adverse pulmonary vascular remodeling in the Fontan circulation. J Heart Lung Transplant. 2015 Mar;34(3):404-13. doi: 10.1016/j.healun.2015.01.005. Epub 2015 Jan 16.
Other Identifiers
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NL51128.042.15
Identifier Type: -
Identifier Source: org_study_id