Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 16 - 80 |
| Updated: | 8/22/2018 |
| Start Date: | November 2013 |
| End Date: | December 2018 |
A Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial Hypertension
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
randomized to placebo vs. 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.
change in pulmonary vascular resistance (PVR) as the primary endpoint.
In this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be
randomized to placebo vs. 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.
Inclusion Criteria:
1. 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
2. Age 16-80
3. WHO Functional Class II or III
4. Right Heart Catheterization within 3 weeks of study entry with mPAP ≥ 25 mmHg, wedge ≤
15 mmHg, and PVR ≥ 3 Wood units.
5. Contraception use, (-) urine pregnancy test, not breast feeding (women of childbearing
potential)
6. 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
Exclusion Criteria:
7. WHO Functional Class IV or listed for lung transplant
8. Moderate or greater obstructive lung disease: FEV1/FVC <70% and FEV1 <60%
9. 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)
10. 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.
1. High probability VQ or positive CTA
2. Left ventricular ejection fraction <40%
11. Depression
12. Severe liver, renal or other medical or physical disease preventing completion of the
study procedures
13. Use of antidepressants within 3 months
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