Status:
COMPLETED
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
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 Description
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...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study-mandated procedure
- PAH of the following subtypes: idiopathic PAH WHO functional class II-III
- Catheterization within one week showing mPAP \>=25, wedge or LV end diastolic pressure ≤15, and PVR \> 4 wood units, and baseline fick cardiac output results available
- Age 16-75
- Able to complete a six minute walk distance
- Women of childbearing potential\*: negative serum pre-treatment pregnancy test + consistently and correctly uses a reliable method of contraception\*\* Oral approved PAH therapy for \>3 months with no change in dose for \> 1 month
Exclusion
- PAH with connective tissue disease, congenital heart disease, portal hypertension, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathy, myeloproliferative disorders.
- Moderate to severe obstructive or restrictive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 70% and FEV1 \< 60% of predicted value after bronchodilator administration. -or- total lung capacity (TLC) \< 60% of predicted.
- Systemic systolic blood pressure \<100 mmHg Breastfeeding
- Significant liver, renal or other medical disease preventing completion of the study procedures or with life expectancy \<12 months, or any other acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00942708
Start Date
September 1 2009
End Date
August 1 2011
Last Update
June 2 2020
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390