Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension
Completed · Phase 1
Conditions studied: Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT03057028
- Run by
- Virginia Commonwealth University
- People needed
- 7
- Starts
- 2016-04-01
- Expected to finish
- 2018-06-07
- Last updated by the study team
- 2019-04-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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