NCT01976533

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
714

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

3.2 years

First QC Date

October 29, 2013

Last Update Submit

December 23, 2015

Conditions

Eisenmenger Syndrome

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    10 years

Study Arms (1)

Advanced therapy, Heart-lung transplantation, dead

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Nordic patients with Eisnemnger syndrome

You may qualify if:

  • Eisenmenger syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dept. Cardiology B, Rigshospitalet

Copenhagen, Denmark

Location

Centers for Adult Congenital Heart Disease

Various, Finland

Location

Centers for Adult Congenital Heart Disease

Various, Norway

Location

Centers for adult congenital heart disease

Various, Sweden

Location

MeSH Terms

Conditions

Eisenmenger Complex

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Lars Soendergaard, MD, DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 6, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2015

Study Completion

October 1, 2016

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

NO(1)FI(1)DK(1)SE(1)