Eisenmenger Syndrome in the Nordic Countries

Eisenmenger Syndrome Clinical Trial

Official title:

Eisenmenger Syndrome in the Nordic Countries: Advanced Treatment and Mortality 1977-2012

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01976533
• Other study ID #: 3-3013-144/1/
• Status: Active, not recruiting
• Phase: N/A
• First received: October 29, 2013
• Last updated: December 23, 2015
• Start date: October 2012
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Health and Medicines AuthoritySweden: Regional Ethical Review BoardFinland: Ethics Committee
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 714
• Est. completion date: October 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

• Eisenmenger syndrome

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Eisenmenger Complex
• Eisenmenger Syndrome
• Syndrome

Locations

Country	Name	City	State
Denmark	Dept. Cardiology B, Rigshospitalet	Copenhagen
Finland	Centers for Adult Congenital Heart Disease	Various
Norway	Centers for Adult Congenital Heart Disease	Various
Sweden	Centers for adult congenital heart disease	Various

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Actelion, Hospital for Children and Adolescents, Finland, Lund University Hospital, Rikshospitalet University Hospital

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		10 years	No