Rapid Switch from Intravenous Epoprostenol to Intravenous Remodulin (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients with Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction

Study Status

Open to Enrollment

Study Description

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 of pulmonary arterial pressure causes an increase in right ventricular tension during heart contraction, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, ameliorate symptoms of PAH and improve health-related quality of life.

The purpose of this eight-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin ® (treprostinil sodium), an FDA-approved therapy for pulmonary arterial hypertension, may offer potential safety and convenience advantages to intravenous Flolan (epoprostenol). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. While Flolan must be changed every 12 to 24 hours (with ice packs) or every eight hours (without ice packs), Remodulin needs changing only every 48 hours. Additionally, since Remodulin remains in the body longer than Flolan (four hours instead of less than five mintues), there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog.

Flolan is administered using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. In an open-label study in Europe, patients were switched from Flolan to Remodulin with no serious side effects. This study will also assess the effect that changing to Remodulin has on treatment satisfaction and patient quality of life.

Participation in this study will last approximately 10 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participants will have four visits during the study and will spend at least one night in the hospital.

Sponsor

United Therapeutics

Key Eligibility

Inclusion criteria:

  • Age 18 to 65 years
  • Diagnosis of one of the following:
    • Idiopathic or familiar pulmonary arterial hypertension (PAH)
    • PAH associated with a collagen vascular disease
    • PAH associated with inherited systemic-to-pulmonary shunt repaired more than five years prior to study entry
    • PAH associated with portal hypertension with mild or moderate hepatic dysfunction (Grade of A or B on the Child-Pugh Classification Scale)
  • WHO Class II-III
  • Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month
  • Have central intravenous catheter
  • Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month
  • Mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump
Exclusion criteria:
  • Nursing or pregnant women
  • Patients with any other type of PAH due to conditions other than those noted in the above inclusion criteria, including but not limited to PAH related to thrombotic or embolic disease
  • Patients with any other disease that is associated with pulmonary hypertension (e.g., sickle cell anemia, schistosomiasis)
  • Patients with changes to chronic PAH therapy, i.e.:
    • new therapy added within last 30 days, including but not limited to oxygen, a different category of vasodilator, a diruetic, digoxin, bosentan, sildenafil
    • PAH medication discontinued within seven days of study entry
  • Patients who have received any prostacyclin or prostacyclin analog other than epoprostenol in the past three months
  • Central venous line infection within the past 30 days
  • Previous documented evidence of significant parenchymal lung disease
  • Evidence or history of left-sided heart disease
  • Musculoskeltal disorder or any other disease thought to limit ambulation, or connection to a machine that is not portable
  • Uncontrolled hypertension, chronic renal insufficiency, anemia or active infection
  • Use of investigational drug within past 30 days

Principal Investigator

Evelyn M. Horn, MD

Contact

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