Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: treprostinil sodium
Intervention description: rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump
Intervention MeSH terms: Treprostinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: pulmonary hypertension; PAH; Remodulin; treprostinil; Quality of Life; Rapid Switch

Summary:

      The purpose of this 8-week study is to compare the effects of switching from therapy with
      epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing
      to Remodulin will have on patient satisfaction with their treatment and impact on quality of
      life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 70 years

          -  Diagnosis of Idiopathic or Familial Pulmonary Arterial Hypertension (PAH)or PAH
             associated with a collagen vascular disease or PAH associated with congenital
             systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH
             associated with portal hypertension with mild or moderate hepatic dysfunction (Grade
             of A or B on the Child-Pugh Classification Scale)or PAH associated with drug or toxins
             or CTEPH

          -  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 woman

          -  Have any other type of PAH due to conditions other than noted in the above inclusion
             criteria, including but not limited to PAH related to thrombotic or embolic disease

          -  Have any other disease that is associated with pulmonary hypertension (e.g. sickle
             cell anemia, schistosomiasis)

          -  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 diuretic, digoxin,
             bosentan, sildenafil] or PAH medication discontinued within 7 days of study entry.

          -  Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3
             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

          -  Musculoskeletal disorder or any other disease, which is thought to limit ambulation,
             or be connected to a machine that is not portable

          -  Uncontrolled hypertension, chronic renal insufficiency, or active infection.

          -  Use of investigational drug within past 30 days.