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Status unknownNCT01976533Updated Dec 24, 2015

Eisenmenger Syndrome in the Nordic Countries

An observational study in Eisenmenger Syndrome, sponsored by Copenhagen University Hospital, Rigshospitalet. Status unknown at 4 sites in 4 countries. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2015-12-24.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Observational

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
714
Ages
Up to 100 Years
Sex
All
01

Study 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 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
02

Conditions studied

  • Eisenmenger Syndrome

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03

In context

Eisenmenger Complex

25 studies on the registry are indexed under Eisenmenger Complex; 5 are open to participants now.

Browse Eisenmenger Complex studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 39 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Nordic patients with Eisnemnger syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Eisenmenger syndrome

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
714 participants (actual)
Patient registry
No

Groups and cohorts

  • Advanced therapy, Heart-lung transplantation, dead
06

What researchers measure

Primary outcomes

  1. All cause mortality

    Time frame: 10 years

07

Study locations

4 sites
  • Dept. Cardiology B, Rigshospitalet
    Copenhagen, Denmark
  • Centers for Adult Congenital Heart Disease
    Various, Finland
  • Centers for Adult Congenital Heart Disease
    Various, Norway
  • Centers for adult congenital heart disease
    Various, Sweden
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2012, a primary completion of Dec 2015 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2013
First posted
Nov 6, 2013
Start
Oct 2012
Primary completionActual
Dec 2015
CompletionEst.
Oct 2016
Last update
Dec 24, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01976533
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Collaborators
Lund University Hospital, Rikshospitalet University Hospital, Hospital for Children and Adolescents, Finland, Actelion
Responsible party
Cristel Sørensen (MD, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Nov 6, 2013
Start date
Oct 2012
Primary completion
Dec 2015
Completion
Oct 2016 (estimated)
Last update
Dec 24, 2015

Study contacts

Lars Soendergaard, MD, DMSc
principal investigator · Copenhagen University Hospital, Rigshospitalet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Copenhagen University Hospital, Rigshospitalet

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