Phase 2
N=8
Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03638908 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Pulmonary Vascular Resistance (PVR) — 6.7 woods unit
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
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Vascular Resistance (PVR) |
6.7 | — |
| SECONDARY 5-HIAA (HYDROXYINDOLE ACETIC ACID) Level |
0.375 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03638908). 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.