Clinical Trial: Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome

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

Detailed Summary:

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.

Same as current

Current Secondary Outcome:

  • Pulmonary blood flow
  • Systemic blood flow
  • Pulmonary resistance
  • Shunt ratio
  • Erythropoitin
  • BNP
  • Saturation in rest
  • Saturation in activity
  • Quality of life
  • Right ventricle systolic and diastolic function
  • Working capacity
  • Oxygen consumption at rest
  • Oxygen consumption during maximal work


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: March 14, 2006
Date Started: March 2006
Date Completion:
Last Updated: January 23, 2008
Last Verified: January 2008