Eisenmenger SyndromeNCT01976533
Eisenmenger Syndrome in the Nordic Countries
An observational study of Eisenmenger Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in 4 countries.
Trial summary
This is a historical cohort study with retrospective collection of data comprising all Nordic patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is to determine prognostic factors for mortality and morbidity. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Eisenmenger Syndrome
- How many people
- 714 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Oct 2012to Oct 2016
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Nordic patients with Eisnemnger syndrome
Who may be able to join
- Eisenmenger syndrome
Who cannot join
- -
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Eisenmenger Syndrome in the Nordic Countries: Advanced Treatment and Mortality 1977-2012
This is a historical cohort study with retrospective collection of data comprising all Nordic patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is to determine prognostic factors for mortality and morbidity.
Read the detailed description
The following variables are obtained from national registries for each individual fulfilling the inclusion criteria:
- Personal data: Gender, day of birth, vital status (dead/alive), date of death, cause of death, all cause hospitalization days
- Specific cardiac malformation diagnosis
- Heart-lung transplantation.
- Social data: Highest educational level, marital status, employment status (Denmark only)
Primary endpoints
- Incidence and prevalence of Eisenmenger Syndrome
- All-cause mortality
- All-cause morbidity (hospitalization for any cause)
- Heart-lung transplantation
- Advanced treatment
- Mortality with AT
- Highest educational level
- Personal income
- Marital status
- Job status
- Conditions
- Eisenmenger Syndrome
- Medical subject headings
- Eisenmenger Complex
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 |
|---|---|---|
| Advanced therapy, Heart-lung transplantation, dead | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eisenmenger SyndromeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Retrospective
- Enrolment
- 714 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University Hospital, Rikshospitalet University Hospital, Hospital for Children and Adolescents, Finland, Actelion
- Responsible party
- Principal investigator, Cristel Sørensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Soendergaard, MD, DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976533
- Sponsor's protocol ID
- 3-3013-144/1/
- Status last verified
- Dec 2015
- First submitted
- 29 Oct 2013
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eisenmenger Syndrome in the Nordic Countries: Advanced Treatment and Mortality 1977-2012
- ClinicalTrials.gov ID
- NCT01976533
- Acronym / sponsor ID
- 3-3013-144/1/
- Conditions
- Eisenmenger Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 714 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Lund University Hospital, Rikshospitalet University Hospital, Hospital for Children and Adolescents, Finland, Actelion
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 6 Nov 2013 (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 is a historical cohort study with retrospective collection of data comprising all Nordic patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is to determine prognostic factors for mortality and morbidity.
Detailed description
The following variables are obtained from national registries for each individual fulfilling the inclusion criteria:
- Personal data: Gender, day of birth, vital status (dead/alive), date of death, cause of death, all cause hospitalization days
- Specific cardiac malformation diagnosis
- Heart-lung transplantation.
- Social data: Highest educational level, marital status, employment status (Denmark only)
Primary endpoints
- Incidence and prevalence of Eisenmenger Syndrome
- All-cause mortality
- All-cause morbidity (hospitalization for any cause)
- Heart-lung transplantation
- Advanced treatment
- Mortality with AT
- Highest educational level
- Personal income
- Marital status
- Job status
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced therapy, Heart-lung transplantation, dead | – | – |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nordic patients with Eisnemnger syndrome
Key inclusion criteria (1 listed)
- Eisenmenger syndrome
Key exclusion criteria (1 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
All cause mortality
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
Related trials for Eisenmenger Syndrome
Not yet recruitingPhase 2
Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome
Congenital Heart Disease (CHD), Eisenmenger Syndrome
RecruitingPhase 4
A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy
Eisenmenger Syndrome, Pulmonary Arterial Hypertension of Congenital Heart Disease
RecruitingObservational study
COMPERA / COMPERA-KIDS
Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH)
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.
Lars Soendergaard, MD, DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eisenmenger Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in 4 countries.
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 1 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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Finland, Norway, Sweden. 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?
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?
All cause mortality (time frame: 10 years). 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 24 Dec 2015.