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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057028
• Other study ID #: HM20005870
• Status: Completed
• Phase: Phase 1
• Start date: April 2016
• Est. completion date: June 7, 2018

Study information

• Verified date: April 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 7, 2018
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Anakinra

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise capacity, as determined by peak oxygen consumption and ventilatory efficiency on cardiopulmonary exercise testing		14 days
Secondary	Effect of anakinra on serum high sensitivity C-reactive protein		14 days
Secondary	Effect of anakinra on serum NT-pro-BNP.		14 days
Secondary	Effect of anakinra on serum interleukin-6		14 days
Secondary	Change in symptoms of heart failure (as assessed by questionnaire with the Duke Activity Status Index and Minnesota Living With Heart Failure Questionnaire).		14 days
Secondary	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)		14 days
Secondary	Number of patients with treatment related adverse events related to anakinra in patients with pulmonary arterial hypertension		14 days