Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial

Completed · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

This protocol describes an open-label phase 2 clinical trial of fluoxetine in PAH looking at change in pulmonary vascular resistance (PVR) as the primary endpoint. In this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be given fluoxetine for 24 weeks. A Right Heart Catheterization will be performed at baseline and 24 weeks. Change in PVR will be the primary endpoint; other hemodynamic endpoints, quality of life, QIDS-SR depression scale, functional class and six-minute walk distance will also be evaluated. Primary Hypothesis: Fluoxetine treatment for 24 weeks will lead to significantly lower pulmonary vascular resistance in 18 patients with PAH in patients treated in an open-label clinical trial.

Key facts

Study ID

NCT03638908

Run by

University of Texas Southwestern Medical Center

People needed

8

Starts

2013-11-01

Expected to finish

2018-12-01

Last updated by the study team

2020-06-26

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• WHO Group I PAH subtypes of idiopathic PAH and PAH associated with drugs / toxins, connective tissue disease, repaired congenital heart disease and unrepaired atrial septal defect
• Age 16-80
• WHO Functional Class II or III
• Right Heart Catheterization within 3 weeks of study entry with mPAP ≥ 25 mmHg, wedge ≤ 15 mmHg, and PVR ≥ 3 Wood units.
• Contraception use, (-) urine pregnancy test, not breast feeding (women of childbearing potential)
• One or more approved PAH therapies for ≥ 3 months, no change in dose for 1 month (endothelin-1 antagonist, phosphodiesterase-5 inhibitor, prostacyclin / prostacyclin analog). Novel approved therapies in one of the three existing classes will also be acceptable as background therapy if they become available during the course of the study; other medication classes are excluded

You may not qualify if…

• WHO Functional Class IV or listed for lung transplant
• Moderate or greater obstructive lung disease: FEV1/FVC <70% and FEV1 <60%
• Moderate or greater restrictive lung disease: TLC or FVC <60% (if 50-60%: OK if TLC or FVC ≥50% + PFT stable x1 year + CT with no more than mild lung disease)
• Other cause for pulmonary hypertension: all other WHO group I diseases (including but not limited to liver disease, HIV), and WHO Groups II-V (i.e. left heart disease, lung disease, chronic PE and miscellaneous causes)24.
• High probability VQ or positive CTA
• Left ventricular ejection fraction <40%
• Depression
• Severe liver, renal or other medical or physical disease preventing completion of the study procedures
• Use of antidepressants within 3 months

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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