Congenital Heart DiseaseNCT02414321
The Role of the Pulmonary Vasculature in the Fontan Circulation
An observational study of Congenital Heart Disease and Fontan Operation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult Fontan patients. Objectives: Determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise. Characterization of structural properties of small pulmonary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease, Fontan Operation, Pulmonary Vascular Resistance
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients (≥18 years), who attend the University Medical Center Groningen for follow-up after a Fontan completion. Additionally 5 adult patients (≥18 years) without a Fontan circulation and without a univentricular heart-like diagnosis but with a clinical indication for right heart catheterization and normal values at right heart catheterization measurements will be included to serve as controls for the pulmonary artery OCT analysis.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Rolf MF Berger, MD PhD
Elke S Hoendermis, MD PhD
About this study
This study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult Fontan patients.
Objectives:
- Determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise.
- Characterization of structural properties of small pulmonary arteries.
Read the detailed description
Rationale:
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
- Congenital Heart Disease, Fontan Operation, Pulmonary Vascular Resistance, Pulmonary Vascular Remodeling
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fontan group | Right heart catheterization: * pulmonary artery OCT analysis * dobutamine stress test * pulmonary vascular response test (nitric oxide) * trans-thoracic echocardiography | |
| Control group | Right heart catheterization: - pulmonary artery OCT analysis | |
| PAH group | Right heart catheterization: - pulmonary artery OCT analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
vasodilatation
change in indexed cardiac output between baseline and after pulmonary vasodilatation
Measured: change in indexed cardiac output between baseline and after 10 minutes of pulmonary vasodilatation at heart catheterization
number of intimal lesions in small pulmonary arteries
number of intimal lesions in small pulmonary arteries
Measured: baseline at heart catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. R.M.F. Berger, University Medical Center Groningen
- Investigators
- Rolf M Berger, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414321
- Sponsor's protocol ID
- NL51128.042.15
- Status last verified
- Nov 2023
- First submitted
- 30 Mar 2015
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Fontan F, Baudet E. Surgical repair of tricuspid atresia. Thorax. 1971 May;26(3):240-8. doi: 10.1136/thx.26.3.240.
PubMed 5089489Wolff 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.
PubMed 24067749de 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.
PubMed 20585329Gewillig 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.
PubMed 19995891Goldberg 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.
PubMed 24401254Khambadkone 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.
PubMed 12821557Ridderbos 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.
PubMed 25813767
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Pulmonary Vasculature in the Fontan Circulation
- ClinicalTrials.gov ID
- NCT02414321
- Acronym / sponsor ID
- NL51128.042.15
- Conditions
- Congenital Heart Disease, Fontan Operation, Pulmonary Vascular Resistance, Pulmonary Vascular Remodeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult Fontan patients.
Objectives:
- Determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise.
- Characterization of structural properties of small pulmonary arteries.
Detailed description
Rationale:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fontan group | – | –Right heart catheterization: * pulmonary artery OCT analysis * dobutamine stress test * pulmonary vascular response test (nitric oxide) * trans-thoracic echocardiography |
| Control group | – | –Right heart catheterization: - pulmonary artery OCT analysis |
| PAH group | – | –Right heart catheterization: - pulmonary artery OCT analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (≥18 years), who attend the University Medical Center Groningen for follow-up after a Fontan completion. Additionally 5 adult patients (≥18 years) without a Fontan circulation and without a univentricular heart-like diagnosis but with a clinical indication for right heart catheterization and normal values at right heart catheterization measurements will be included to serve as controls for the pulmonary artery OCT analysis.
Key inclusion criteria (8 listed)
- Fontan group
- written informed consent
- Clinical indication for cardiac catheterization
- Control group
- written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vasodilatation
Time frame: change in indexed cardiac output between baseline and after 10 minutes of pulmonary vasodilatation at heart catheterization
change in indexed cardiac output between baseline and after pulmonary vasodilatation
number of intimal lesions in small pulmonary arteries
Time frame: baseline at heart catheterization
number of intimal lesions in small pulmonary arteries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 5089489Fontan F, Baudet E. Surgical repair of tricuspid atresia. Thorax. 1971 May;26(3):240-8. doi: 10.1136/thx.26.3.240.
- Background: PubMed 24067749Wolff 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.
- Background: PubMed 20585329de 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.
- Background: PubMed 19995891Gewillig 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.
- Background: PubMed 24401254Goldberg 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.
- Background: PubMed 12821557Khambadkone 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.
- Background: PubMed 25813767Ridderbos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf M Berger, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Fontan Operation, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Floris-Jan S Ridderbos, MD (+31503611506, f.j.s.ridderbos@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vasodilatation (time frame: change in indexed cardiac output between baseline and after 10 minutes of pulmonary vasodilatation at heart catheterization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414321, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.