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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Virginia Commonwealth University

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Virginia Commonwealth University

Dates:
Date Received: May 4, 2016
Date Started: April 2016
Date Completion: April 2019
Last Updated: May 18, 2017
Last Verified: May 2017