NCT03057028

Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pulmonary arterial hypertension (PAH) can result in right ventricular failure and death. Anakinra has been used in patients with left sided heart failure, and the present study looks to determine if anakinra is safe and effective in patients with PAH. To accomplish this goal, we plan to evaluate for exercise improvement (as assessed by cardiopulmonary exercise testing) in 10 patients with PAH on anakinra.

Detailed description

Patients with pulmonary arterial hypertension will undergo cardiopulmonary exercise testing (CPET) at baseline and at 2 weeks. After the initial CPET, all patients will receive anakinra as a daily injection for 2 weeks. Patients will be instructed in the use of anakinra during their initial visit. Our primary outcome will be the difference in the exercise capacity of patients with PAH, as measured by maximal uptake of oxygen on CPET.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Anakinra

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2017-02-17
• Last updated: 2019-04-05

Locations

1 site across 1 country: United States