Eisenmenger Syndrome in the Nordic Countries | NCT01976533

Studies
Eisenmenger Syndrome in the Nordic Countries

NCT01976533

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Dec 24, 2015Estimated

Enrollment

714Actual

Phase

Not provided

Conditions

Eisenmenger Syndrome

Interventions

Not provided

Countries

Denmark
Finland
Norway
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 2015Actual

Completion Date

Oct 2016Estimated

First Submitted Date

Oct 29, 2013

First Submission Date that Met QC Criteria

Oct 29, 2013

First Posted Date

Nov 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2015

Last Update Posted Date

Dec 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cristel Sørensen, MD, Rigshospitalet, DenmarkPrincipal Investigator

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Name	Class
Lund University Hospital	OTHER
Rikshospitalet University Hospital	OTHER
Hospital for Children and Adolescents, Finland	OTHER
Actelion

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

714Actual

Label	Type	Description	Intervention Names
Advanced therapy, Heart-lung transplantation, dead

Measure	Description	Time Frame
All cause mortality		10 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eisenmenger syndrome

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Nordic patients with Eisnemnger syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Soendergaard, MD, DMSc	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Cardiology B, Rigshospitalet		Copenhagen			Denmark
Centers for Adult Congenital Heart Disease

Condition Browse Module

MeSH Terms

ID	Term
D004541	Eisenmenger Complex

Ancestor Terms

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided