Eisenmenger's SyndromeNCT01283958
The Effects of Inhaled Iloprost on Congenital Heart Disease With Eisenmenger Syndrome
An observational study of Eisenmenger's Syndrome, run by Gachon University Gil Medical Center.
Trial summary
Identification of the pathophysiology associated with Eisenmenger's syndrome has led to the evaluation of targeted therapies. Iloprost, a prostacyclin analogue, is one such targeted therapy used in patients with Eisenmenger's syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eisenmenger's Syndrome
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to May 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 12 patients with Eisenmenger's syndrome diagnosed by right side cardiac catheterization
Who may be able to join
- patients with Eisenmenger's syndrome diagnosed by right side cardiac catheterization
Who cannot join
None listed.
About this study
Official title: Study of the Effects of Inhaled Iloprost on Congenital Heart Disease With Eisenmenger Syndrome
Identification of the pathophysiology associated with Eisenmenger's syndrome has led to the evaluation of targeted therapies. Iloprost, a prostacyclin analogue, is one such targeted therapy used in patients with Eisenmenger's syndrome. The purpose of our study is to assess the effects of inhaled iloprost on patients with Eisenmenger's syndrome.
- Conditions
- Eisenmenger's Syndrome
- Keywords
- Iloprost, Eisenmenger's syndrome
- Medical subject headings
- Eisenmenger Complex
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startSep 2007
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eisenmenger's SyndromeStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283958
- Sponsor's protocol ID
- no sponsor
- Status last verified
- May 2010
- First submitted
- 25 Jan 2011
- Last updated
- 26 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Inhaled Iloprost on Congenital Heart Disease With Eisenmenger Syndrome
- ClinicalTrials.gov ID
- NCT01283958
- Acronym / sponsor ID
- no sponsor
- Conditions
- Eisenmenger's Syndrome
- Keywords
- Iloprost, Eisenmenger's syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- May 2010 (actual)
- First posted
- 26 Jan 2011 (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.
Identification of the pathophysiology associated with Eisenmenger's syndrome has led to the evaluation of targeted therapies. Iloprost, a prostacyclin analogue, is one such targeted therapy used in patients with Eisenmenger's syndrome. The purpose of our study is to assess the effects of inhaled iloprost on patients with Eisenmenger's syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 12 patients with Eisenmenger's syndrome diagnosed by right side cardiac catheterization
Key inclusion criteria (1 listed)
- patients with Eisenmenger's syndrome diagnosed by right side cardiac catheterization
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 26 Jan 2011.
Related trials for Eisenmenger's Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Eisenmenger's Syndrome, run by Gachon University Gil Medical Center.
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 1 inclusion and 0 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 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
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 26 Jan 2011.