Eisenmenger Syndrome in the Nordic Countries

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.

Study Overview

• Status: Unknown
• Conditions: Eisenmenger Syndrome

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 Type: Observational
• Enrollment (Actual): 714

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Dept. Cardiology B, Rigshospitalet
• Finland
  • Various, Finland
    • Centers for adult congenital heart disease
• Norway
  • Various, Norway
    • Centers for adult congenital heart disease
• Sweden
  • Various, Sweden
    • Centers for adult congenital heart disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Nordic patients with Eisnemnger syndrome

Description

Inclusion Criteria:

• Eisenmenger syndrome

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Advanced therapy, Heart-lung transplantation, dead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	10 years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Rikshospitalet University Hospital; Actelion; Lund University Hospital; Hospital for Children and Adolescents, Finland
• Investigators: Principal Investigator: Lars Soendergaard, MD, DMSc, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: October 29, 2013
• First Posted (Estimate): November 6, 2013

Study Record Updates

• Last Update Posted (Estimate): December 24, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Syndrome; Eisenmenger Complex
• Other Study ID Numbers: 3-3013-144/1/