Eisenmenger Syndrome in the Nordic Countries

• Conditions: Eisenmenger Syndrome

• Registration Number: NCT01976533
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-06
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-24
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 714

Inclusion Criteria

• Eisenmenger syndrome

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	10 years

Trial Locations

Locations (3)

Dept. Cardiology B, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Centers for Adult Congenital Heart Disease; 🇳🇴 Various, Norway

Centers for adult congenital heart disease; 🇸🇪 Various, Sweden