Pulmonary Arterial Hypertension Clinical Trial
Official title:
A Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to Placebo
SUMMARY Rationale: Pulmonary arterial hypertension (PAH) can be a rapidly progressive
disorder and is associated with a high mortality rate, despite medical intervention. With the
availability of effective therapy, early disease detection is an important strategic
objective to improve treatment outcomes. Resting echocardiography is currently the
recommended screening modality for high-risk population groups. However, it is clear that
abnormalities in resting hemodynamics (and symptoms) are late sequelae of the pathobiological
processes that begin in the distal pulmonary arteries. Exercise stress may unmask early
pulmonary vascular dysfunction, however the definition, clinical significance, and natural
history of 'exercise PAH' remain undefined. However, based on clinical experience and
literature the prevalence is estimated at ~ 20%.Treatment with endothelin receptor blockers
has shown a beneficial influence on the clinical performance in patients with exercise
induced PAH due to systemic sclerosis and primary pulmonary hypertension. Whether endothelin
receptor blockers decrease pulmonary pressures and improve clinical outcome in patients with
exercise induced pulmonary arterial hypertension due to congenital heart disease is unknown.
Objective: Identify congenital heart disease patients with exercise-induced pulmonary
arterial hypertension. Analyze changes in pulmonary arterial pressures at peak exercise in
patients with exercise induced pulmonary arterial hypertension before and after treatment
with bosentan, compared to placebo.
Study design: Randomized placebo controlled trial with a study period of 26 weeks.
Study population: Adult congenital heart disease patients with exercise induced pulmonary
arterial hypertension (n=40) from the Academic Medical Centre, Amsterdam.
Intervention: After randomization one group (n=20) receives a 125 mg tablet of Bosentan twice
daily for 6 months. The other group (n=20) receives placebo for 6 months.
Main study parameters/endpoints: To determine wether bosentan (endothelin receptor inhibitor)
decreases mean pulmonary arterial pressure at peak exercise in adult congenital heart disease
patients with exercise induced pulmonary arterial hypertension. Furthermore the change in
cardiopulmonary exercise capacity and right ventricular function will be investigated.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: All investigations, blood analysis excepted, are non-invasive and free of risk.
The burden for the patients mainly consists of the time that is consumed by the
investigations, namely: history taking + physical examination (15 min); Quality-of-Life-
score (15 min); laboratory tests (electrolytes, creatinine, urea, albumin and neurohormones,
troponin T); 12 lead electrocardiogram (10 min); exercise echocardiography (30 min);
cardiovascular exercise testing (30 min).
The trial medication has a potential risk of liver damage, which will be monitored regularly
by laboratory testing of liver transaminases.
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