Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan CirculationPhase 2NCT00263406
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
A Phase 2 study testing Administration of an ACE-inhibitor or not in people with Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Randomisation between postoperative administration of an ACE-inhibitor or not. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation
- What is being tested?
- Administration of an ACE-inhibitor or not
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2002to Mar 2007
- Phase
- Phase 2
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All consecutive children with a univentricular heart disease undergoing elective surgery for creation of a Fontan circulation
- Parents have agreed with the study after informed consent
Who cannot join
- Urgent / Emergent surgery
- Preoperative use of an ACE-inhibitor
Trial locations and contacts
1 site in 1 country.
About this study
Randomisation between postoperative administration of an ACE-inhibitor or not.
Read the detailed description
Children that are undergoing elective surgery for the creation of a Fontan circulation will be randomised to postoperative administration of an ACE-inhibitor or not.
Determination of aldosteron, renine and ADH in serum preoperatively and 1h, 12h and 5 days postoperatively.
- Conditions
- Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation
- Being tested
- Administration of an ACE-inhibitor or not
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of an ACE-inhibitor or notDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the pleural drainage in the first two postoperative weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startDec 2002
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan CirculationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Guy Van Nooten, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263406
- Sponsor's protocol ID
- 2002/055
- Status last verified
- Dec 2007
- First submitted
- 4 Dec 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
- ClinicalTrials.gov ID
- NCT00263406
- Acronym / sponsor ID
- 2002/055
- Conditions
- Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Dec 2002
- Study completion
- Mar 2007 (actual)
- First posted
- 8 Dec 2005 (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.
Randomisation between postoperative administration of an ACE-inhibitor or not.
Detailed description
Children that are undergoing elective surgery for the creation of a Fontan circulation will be randomised to postoperative administration of an ACE-inhibitor or not.
Determination of aldosteron, renine and ADH in serum preoperatively and 1h, 12h and 5 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All consecutive children with a univentricular heart disease undergoing elective surgery for creation of a Fontan circulation
- Parents have agreed with the study after informed consent
Key exclusion criteria (2 listed)
- Urgent / Emergent surgery
- Preoperative use of an ACE-inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of an ACE-inhibitor or not | Drug | – |
Primary outcome
Duration of the pleural drainage in the first two postoperative weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- Website of the University Hospital GhentLink provided by the sponsor.
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.
Guy Van Nooten, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of an ACE-inhibitor or not in people with Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Dec 2007. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the pleural drainage in the first two postoperative weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2007.