Phase 2
N=6
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00942708 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
May 2019
Primary outcome: Primary: Change in Pulmonary Vascular Resistance (PVR) at Three Months — -0.49 Wood units — p=0.09
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluoxetine (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pulmonary Vascular Resistance (PVR) at Three Months |
-0.49 | 0.09 |
| SECONDARY Change Between Baseline and Three Month in the QIDS-SR Depression Scale |
1 | — |
| SECONDARY Change in Six Minute Walk Distance at 3 Months |
10 | — |
Summary
This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for three months among patients with pulmonary arterial hypertension.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00942708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.