Pulmonary Arterial Hypertension Clinical Trial
Official title:
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
Verified date | May 2020 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for three months among patients with pulmonary arterial hypertension.
Status | Completed |
Enrollment | 6 |
Est. completion date | August 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | National Center for Research Resources (NCRR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pulmonary Vascular Resistance (PVR) at Three Months | PVR will be measured by right heart catheterization at baseline and 3 months. Change in PVR will be determined by baseline value minus 3 month value. | Change in PVR at 3 mos (Baseline - 3 months) | |
Secondary | Change Between Baseline and Three Month in the QIDS-SR Depression Scale | The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) depression scale is a questionnaire completed by the patient. Lower scores are better. Scoring can be interpreted as 7 or less: normal, 8-12: mild depression, 13-16 moderate depression, 17-20 moderate to severe depression and >20 severe depression. Results here show the median change between baseline and 3 months, making a positive change in score indicative of improvement. Total minimum score is 0 and the maximum is 27. | Baseline - 3 months (median change) | |
Secondary | Change in Six Minute Walk Distance at 3 Months | Six minute walk distance will be measured at baseline and after 3 months of fluoxetine. Change in walk distance (mean and SD) will be reported by taking subtracting baseline values from result at 3 months. | 3 months |
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