This trial is active, not recruiting.

Condition eisenmenger syndrome
Sponsor Rigshospitalet, Denmark
Collaborator Lund University Hospital
Start date October 2012
End date December 2015
Trial size 714 participants
Trial identifier NCT01976533, 3-3013-144/1/


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

All cause mortality
time frame: 10 years

Eligibility Criteria

Male or female participants up to 100 years old.

Inclusion Criteria: - Eisenmenger syndrome Exclusion Criteria:

Additional Information

Official title Eisenmenger Syndrome in the Nordic Countries: Advanced Treatment and Mortality 1977-2012
Principal investigator Lars Soendergaard, MD, DMSc
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.