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

• Status: Completed
• Trial end date: 2018-06-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• age over 18

• functional class II or III symptoms of right ventricular failure despite optimal PAH therapy

• mean pulmonary artery pressure >25mmHg on previous right heart catheterization

• pulmonary arterial wedge pressure <15mmHg on previous right heart catheterization

• pulmonary vascular resistance >3 wood units on previous right heart catheterization

Exclusion Criteria:

• PAH due to connective tissue disease

• angina or electrocardiograph changes that limit maximum exertion during cardiopulmonary exercise testing or baseline EKG changes that limit the ability to detect ischemia

• recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), chronic inflammatory disorder, malignancy, active infection, or any comorbidity limiting survival or ability to complete the study

• sever kidney dysfunction (eGFR <30mL/min)

• thrombocytopenia (<50,000/mm3), or neutropenia (absolute neutrophil count <1500/mm3)

• refusal by a woman of childbearing potential to use a medically acceptable form of birth control

• history of hypersensitivity to anakinra or E. coli products

• latex or rubber allergy

• inability to give informed consent

• non-English speaking