Pulmonary Arterial Hypertension | Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension research study
What is the primary objective of this study?
This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for three months among patients with pulmonary arterial hypertension.
Who is eligible to participate?
Inclusion Criteria: 1. Signed informed consent prior to any study-mandated procedure 2. PAH of the following subtypes: idiopathic PAH WHO functional class II-III 3. 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 4. Age 16-75 5. Able to complete a six minute walk distance 6. 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 Criteria: 1. PAH with connective tissue disease, congenital heart disease, portal hypertension, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathy, myeloproliferative disorders. 2. 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. 3. Systemic systolic blood pressure <100 mmHg Breastfeeding 4. 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Pulmonary Arterial Hypertension
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:FluoxetineTotal 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
FluoxetineFluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.
Start Date: September 2009
Completed Date: August 2011
Phase: Phase 2
Primary Outcome: The primary endpoint will be change in pulmonary vascular resistance (PVR) measured by right heart catheterization after three months of therapy.
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
Study sponsors, principal investigator, and references
Principal Investigator: Kelly M Chin, MD
Lead Sponsor: University of Texas Southwestern Medical Center