A phase 2, open-label, clinical trial of fluoxetine, a selective serotonin reuptake inhibitor, in the treatment of pulmonary arterial hypertension

Study ID
STU 082013-045

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Adetoun Sodimu
214-645-6489
adetoun.sodimu@utsouthwestern.edu

Principal Investigator
Kelly Chin

Summary

This is a phase ii single center open-label study enrolling 18 patients with PaH. Patients will be on fluoxetine for 6 months, undergoing testing catheterization at baseline or just prior to baseline and at 6 months. an estimated 3 years will be required to complete enrollment. Fluoxetine dose will be initiated at 20 mg, with dose titration every 4 weeks to a maximum of 80 mg daily, as tolerated. The primary objective will be to determine whether fluoxetine leads to improvement in PVR; secondary endpoints include 6MWD, quality of life, functional class and safety.

Participant Eligibility

Inclusion for Control Patients
1. Not genetically related to a PH patient
2. No significant heart or lung disease
3. No history of carcinoid
4. Not on an SSRI or TCA
5. Willing to avoid Tylenol, aspirin and guaifenasin for 48 hours
6. Willing to follow diet recommendation for 72 hours: No avocados, bananas, butternuts, cantaloupe, dates, eggplant, grapefruit, hickory nuts, honeydew melon, kiwifruit, melons, nuts, pecans, pineapple, plantains, plums, tomatoes and tomato products, or walnuts for 72 hours before collection

Controls for 5HIAA substudy
: 16 normal controls will be identified through clinic x unrelated family members of patients with PAH will be eligible for the substudy

Incusion for patients

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, diagnosed by complete work-up (VQ or CTA, echo, labs, PFTs, catheterization)*
2. Age 16-80
3. WHO Functional Class II or III (definition in
* procedures
* below)
4. 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