Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for three months among patients with pulmonary arterial hypertension.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension|
- The primary endpoint will be change in pulmonary vascular resistance (PVR) measured by right heart catheterization after three months of therapy. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Efficacy, Safety and tolerability endpoints will include change between baseline and three month QIDS-SR depression scale, systolic and diastolic blood pressure (systemic) and tabulation of adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Study Completion Date:||August 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.
Total dose How to take:
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-6 40 mg BID Week 7-12 40mg BID
Idiopathic pulmonary arterial hypertension (PAH) is a life-threatening disorder of uncertain cause that leads to progressive right heart failure and death. Average survival has improved from about 2.8 years in the early 1990s to approximately 5-7 years with current treatments, but most patients will still die of their disease. Two classes of oral medications are approved for use in PAH: endothelin-1 antagonists, and phosphodiesterase-5 inhibitors. Both improve walk distance and symptoms in PAH, but most patients still have continued dyspnea, fatigue and significant elevations in pulmonary pressures. Those who remain severely impaired are generally started on a continuous intravenous prostacyclin. For those who are less ill but still symptomatic, few options are available.
Primary endpoint: the primary endpoint will be change in pulmonary vascular resistance (PVR) measured by right heart catheterization after three months of therapy.
- Other three month catheterization variables: right atrial pressure, pulmonary arterial pressure, Fick cardiac output, pulmonary arterial oxygen saturation, pulmonary capillary wedge pressure
- Six minute walk distance
- WHO functional class
- Brain natriuretic peptide
Safety and tolerability endpoints will include change between baseline and three month QIDS-SR depression scale, systolic and diastolic blood pressure (systemic) and tabulation of adverse events to include but not limited to:
- Symptomatic hypotension
- Gastrointestinal side effects
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942708
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Kelly M Chin, MD||UT Southwestern Medical Center|