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Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303004
Recruitment Status : Completed
First Posted : March 15, 2006
Last Update Posted : January 24, 2008
Information provided by:
Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Eisenmenger Syndrome Drug: Bosentan and Sildenafil Phase 3

Detailed Description:

Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).

Several clinical trials have shown that there is a beneficial effect of treating patients with primary pulmonary arterial hypertension with Bosentan or Sildenafil and that a combination of these may have an additive or even synergistic effect. No clinical trials with Sildenafil and Bosentan has been conducted for patients with Eisenmengers syndrome. Observational studies and case stories indicate however that the effect of Bosentan or Sildenafil in patients with Eisenmengers syndrome may be as promising in these patients as in patients with primary pulmonary arterial hypertension.

We would like to examine the effect of treating patients with Eisenmengers Syndrome with a combination of Bosentan and Sildenafil.

The primary end point is change in physical performance measured with six minutes walking test.

Secondary end points is change in saturation, NYHA class, cardiac output (cardiac catheterization and innocor measurement), pulmonary vascular resistance (cardiac catheterization) shunt ratio (MRI), strain of right ventricle (BNP and echocardiography), quality of life and serum erythropoitin.

The trial is designed as a randomized, single centre, placebo controlled, double blind cross over study.

Twenty patients with Eisenmengers syndrome is included. All patients will be treated in three months with Bosentan. There after patients will be randomized to receive either Sildenafil (50 mg tid) or placebo as add on therapy for three month. Hereafter a cross over will be made and patients in combination treatment will receive only their native treatment and vice versa.

Examinations for primary and secondary endpoints will be made at baseline, before cross over and at the end of the study. All up titrating of medication will be performed during admittance. Patients will during the study period be close monitored with registration of adverse advents, physical examination and blood tests.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
Study Start Date : March 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 6 minutes walking distance

Secondary Outcome Measures :
  1. Pulmonary blood flow
  2. Systemic blood flow
  3. Pulmonary resistance
  4. Shunt ratio
  5. Erythropoitin
  6. BNP
  7. Saturation in rest
  8. Saturation in activity
  9. Quality of life
  10. Right ventricle systolic and diastolic function
  11. Working capacity
  12. Oxygen consumption at rest
  13. Oxygen consumption during maximal work

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eisenmenger syndrome
  • Negative pregnancy test

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00303004

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Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Lars Soendergaard, MD Rigshospitalet, Denmark
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kasper Iversen, Rigshospitaler Identifier: NCT00303004    
Other Study ID Numbers: 01000
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: January 24, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
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Eisenmenger Complex
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antihypertensive Agents
Endothelin Receptor Antagonists