Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00942708
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Kelly M Chin, University of Texas Southwestern Medical Center

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

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Fluoxetine Phase 2

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 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

  • Six minute walk distance
  • QIDS-SR depression scale

Safety and tolerability endpoints will include a tabulation of adverse events to include but not limited to:

  • Death
  • Hospitalization
  • Symptomatic hypotension
  • Gastrointestinal side effects
  • Depression

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
Study Start Date : September 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011


Arm Intervention/treatment
Fluoxetine
Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.
Drug: Fluoxetine

Total 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

Other Names:
  • Total 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




Primary Outcome Measures :
  1. Change in Pulmonary Vascular Resistance (PVR) at Three Months [ Time Frame: Change in PVR at 3 mos (Baseline - 3 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.


Secondary Outcome Measures :
  1. Change Between Baseline and Three Month in the QIDS-SR Depression Scale [ Time Frame: Baseline - 3 months (median change) ]
    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.

  2. Change in Six Minute Walk Distance at 3 Months [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942708


Locations
Layout table for location information
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Kelly M Chin, MD UT Southwestern Medical Center

Layout table for additonal information
Responsible Party: Kelly M Chin, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00942708    
Other Study ID Numbers: CTSA NIH Grant UL1-RR024982
First Posted: July 21, 2009    Key Record Dates
Results First Posted: May 22, 2019
Last Update Posted: May 22, 2019
Last Verified: April 2019
Keywords provided by Kelly M Chin, University of Texas Southwestern Medical Center:
Pulmonary Arterial Hypertension
Pulmonary Hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors