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

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 1

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Anakinra

Study type: Interventional

Funder types: Other

Identifiers

NCT03057028

HM20005870

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

anakinra

Experimental group

Description:

Patients will be treated with anakinra, injected SQ daily in a dose of 100mg for 14 days. Before and after this intervention, patients will undergo cardiopulmonary exercise testing (as well as echocardiography, EKG analysis, and serologic analysis). Subjects will be assessed for changes in exercise capacity, as determined by peak oxygen uptake and ventilatory efficiency to CO2 production slope.

Treatment:

Drug: Anakinra