Eisenmenger Syndrome Clinical Trial
Official title:
Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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