Clinical Trial: Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension

Brief Summary: This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for three months among patients with pulmonary arterial hypertension.

Detailed Summary:

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.

Secondary endpoints

Efficacy:

  • 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:

  • Death
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    Sponsor: University of Texas Southwestern Medical Center

    Current Primary Outcome: 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 ]

    Original Primary Outcome: The primary endpoint will be change in pulmonary vascular resistance (PVR) measured by right heart catheterization after six months of therapy. [ Time Frame: 6 months ]

    Current Secondary Outcome: 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 ]

    Original Secondary Outcome: Efficacy, Safety and tolerability endpoints will include change between baseline, three month and six month QIDS-SR depression scale, systolic and diastolic blood pressure (systemic) and tabulation of adverse events [ Time Frame: 6 months ]

    Information By: University of Texas Southwestern Medical Center

    Dates:
    Date Received: July 19, 2009
    Date Started: September 2009
    Date Completion:
    Last Updated: June 10, 2015
    Last Verified: June 2015