Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction
treprostinil sodium
Cardiovascular Diseases+3
+ Hypertension
+ Hypertension, Pulmonary
Treatment Study
Summary
Study start date: September 1, 2006
Actual date on which the first participant was enrolled.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 health related quality of life (HRQOL). Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the IV and SC routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Furthermore, since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension using the CADD legacy pump. 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 4 visits during the study and will spend at least 1 night in the hospital.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location