Clinical Trial: Eisenmenger Syndrome in the Nordic Countries

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:

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

Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: All cause mortality [ Time Frame: 10 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rigshospitalet, Denmark

Dates:
Date Received: October 29, 2013
Date Started: October 2012
Date Completion: October 2016
Last Updated: December 23, 2015
Last Verified: December 2015