Hypertension, Pulmonary Clinical Trial
Official title:
Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction
The purpose of this study is to compare the effects of switching from inhaled Ventavis to intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis therapy. This study is intended to provide information on the safe transition from Ventavis to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life and treatment satisfaction compared to Ventavis.
Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary
arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality
common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure
causes an increase in right ventricular afterload, impairing right ventricular function and
ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen
survival time, to ameliorate symptoms of PAH and to improve quality of life (QOL).
Remodulin (treprostinil sodium), a prostacyclin analog, possesses potent pulmonary and
systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Remodulin
is an approved pharmacotherapy for PAH delivered as either a continuous subcutaneous
infusion or intravenous infusion. Ventavis (iloprost)is an inhaled prostacyclin analogue
with similar properties to Remodulin. In December 2004, Ventavis was approved for use in the
United States by the FDA for the treatment of pulmonary arterial hypertension (WHO Group I)
for patients with NYHA III or IV symptoms.
As the PAH community gains experience with the use of inhaled Ventavis, questions have
arisen as to how to transition a patient on inhaled Ventavis to Remodulin in the presence of
worsening symptoms or at a patient's request related to dissatisfaction with the frequency
of daily treatments. This study will examine effects of switching from Ventavis to IV
Remodulin and compare changes in exercise capacity, safety, HRQOL and treatment
satisfactions.
Participation will last up to 12 weeks. Study procedures include routine blood tests,
medical history, physical exams, disease evaluation, exercise tests and patient
questionnaires. Participates will have 4 clinic visits during the study and will spend at
least one night in the hospital.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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