NCT00303004

Brief Summary

The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 24, 2008

Status Verified

January 1, 2008

Enrollment Period

1.8 years

First QC Date

March 14, 2006

Last Update Submit

January 23, 2008

Conditions

Eisenmenger Syndrome

Outcome Measures

Primary Outcomes (1)

  • 6 minutes walking distance

Secondary Outcomes (13)

  • Pulmonary blood flow

  • Systemic blood flow

  • Pulmonary resistance

  • Shunt ratio

  • Erythropoitin

  • +8 more secondary outcomes

Interventions

Bosentan and SildenafilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eisenmenger syndrome
  • Negative pregnancy test

You may not qualify if:

  • Elevated liver enzymes to more than 3´times normal value
  • Hypotension (SBP \< 90 mmhg).
  • Mandatory treatment with nitrates
  • Myocardial infarction within 3 months
  • Stroke within 3 months
  • Known allergy to Bosentan or Sildenafil
  • inherited degenerative diseases in retina
  • Breast feeding
  • Suspicion of risc of noncompliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Iversen K, Jensen AS, Jensen TV, Vejlstrup NG, Sondergaard L. Combination therapy with bosentan and sildenafil in Eisenmenger syndrome: a randomized, placebo-controlled, double-blinded trial. Eur Heart J. 2010 May;31(9):1124-31. doi: 10.1093/eurheartj/ehq011. Epub 2010 Mar 3.

    PMID: 20202971DERIVED

MeSH Terms

Conditions

Eisenmenger Complex

Interventions

BosentanSildenafil Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Lars Soendergaard, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 15, 2006

Study Start

March 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 24, 2008

Record last verified: 2008-01

Locations

DK(1)