Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT01976533
Status:
UNKNOWN
Last Update Posted:
2015-12-24
First Post:
2013-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eisenmenger Syndrome in the Nordic Countries
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Eisenmenger Syndrome in the Nordic Countries: Advanced Treatment and Mortality 1977-2012
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: