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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03057028
• Date of registration: 04/05/2016
• Prospective Registration: No
• Primary sponsor: Virginia Commonwealth University
• Public title: Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension
• Scientific title: Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension
• Date of first enrolment: April 2016
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03057028
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Dan Grinnan, MD
• Affiliation: Virginia Commonwealth University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Anakinra

Primary Outcome(s)

Change in exercise capacity, as determined by peak oxygen consumption and ventilatory efficiency on cardiopulmonary exercise testing [Time Frame: 14 days]

Secondary Outcome(s)

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]

Effect of anakinra on serum NT-pro-BNP. [Time Frame: 14 days]

Effect of anakinra on serum interleukin-6 [Time Frame: 14 days]

Effect of anakinra on serum high sensitivity C-reactive protein [Time Frame: 14 days]

Secondary ID(s)

HM20005870

Source(s) of Monetary Support

Please refer to primary and secondary sponsors