Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: treprostinil sodium
Intervention description: rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
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: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pulmonary arterial hypertension; treatment satisfaction; rapid switch; remodulin; Quality of life

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:

          -  Be between 18 years and 70 years of age

          -  Be male or if female, be physiologically incapable of childbearing or practicing an
             acceptable method of birth control (women of childbearing potential must have a
             negative pregnancy test).

          -  Have a current World Health Organization (WHO) functional classification of II-III
             status

          -  Diagnosis of one of the following WHO Classifications of pulmonary hypertension: Group
             1 pulmonary arterial hypertension (IPAH, FPAH, APAH);Group 3 pulmonary hypertension
             associated with lung disease (Mild interstitial lung disease associated with
             predominant features of right heart failure as seen in Group 1 PAH patients); Group 4
             pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)

          -  In the opinion of the investigator, be hemodynamically stable with no signs or
             symptoms of disease progression

          -  Be receiving intravenous epoprostenol therapy for at least three months and a stable
             dose for at least one month prior to Baseline.

          -  Have a central intravenous catheter in place.

          -  Have a baseline six-minute walk distance of at least 150 meters.

          -  Be optimally treated with conventional pulmonary hypertension therapy and clinically
             stable for at least one month prior to baseline assessments.

          -  Be mentally and physically capable of learning to administer Remodulin using an
             intravenous infusion pump.

        Exclusion Criteria:

          -  Be a nursing or pregnant woman

          -  Have had a new type of chronic therapy (including but not limited to oxygen, a
             different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil) for
             pulmonary hypertension added within the last month.

          -  Have any PAH medication discontinued within the week prior to study entry.

          -  Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3
             months.

          -  Have an on-going central venous line infection within the past 30 days.

          -  Have evidence of predominant left-sided heart disease

          -  Have any other disease that is associated with pulmonary hypertension (e.g. sickle
             cell anemia, schistosomiasis).

          -  Have a musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other
             disease, which is thought to limit ambulation, or be connected to a machine, which is
             not portable.

          -  Have uncontrolled systemic hypertension as evidenced by a systolic blood pressure
             greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.

          -  Be receiving an investigational drug, have in place an investigational device, or have
             participated in an investigational drug study within the past 30 days.

          -  Have the presence of any physiological or psychological condition that contraindicates
             the administration of Remodulin.