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

NCT ID: NCT03057028

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-06-07

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anakinra

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.

Group Type: EXPERIMENTAL

Anakinra

Intervention Type: DRUG

Interventions

Anakinra

Intervention Type: DRUG

Other Intervention Names

Kineret

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Grinnan, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20005870

Identifier Type: -

Identifier Source: org_study_id