Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT03057028
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03057028
Study Brief:
Protocol Section:
NCT03057028