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

Virginia Commonwealth University7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

AnakinraDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Change in exercise capacity, as determined by peak oxygen consumption and ventilatory efficiency on cardiopulmonary exercise testing

Time frame: 14 days

Secondary Outcomes

Effect of anakinra on serum high sensitivity C-reactive protein

Time frame: 14 days

Effect of anakinra on serum NT-pro-BNP.

Time frame: 14 days

Effect of anakinra on serum interleukin-6

Time frame: 14 days

Change in symptoms of heart failure (as assessed by questionnaire with the Duke Activity Status Index and Minnesota Living With Heart Failure Questionnaire).

Time frame: 14 days

Correlate between biomarkers (serum high sensitivity C reactive protein, interluekin-6, and NT-pro BNP) and measures of exercise capacity (peak oxygen consumption and ventilatory efficiency on cardiopulmonary exercise testing)

Time frame: 14 days

Number of patients with treatment related adverse events related to anakinra in patients with pulmonary arterial hypertension

Time frame: 14 days

Data from ClinicalTrials.gov

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