Pulmonary Hypertension Clinical Trial
Official title:
Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension
Verified date | October 2017 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label non-randomized, pilot study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with pulmonary hypertension. Subjects will undergo cardiopulmonary exercise testing at baseline, and after 4 weeks treatment with Anakinra (recombinant human Interleukin-1 receptor antagonist.
Status | Terminated |
Enrollment | 2 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >18 years - Diagnosis of PAH (from prior right heart catheterization), with functional class III symptoms of right ventricle failure despite optimal PAH therapy - Mean pulmonary artery pressure >25 mmHg - Pulmonary capillary wedge pressure <15 mmHg - Pulmonary vascular resistance >3 wood units Exclusion Criteria: - PAH due to connective tissue disease (including scleroderma), interstitial lung disease (total lung capacity <65% predicted value), or cirrhosis (portopulmonary hypertension) - Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing or baseline ECG changes that limit the ability to detect ischemia (i.e. left bundle-branch block). - Recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, active infection, or any comorbidity limiting survival or ability to complete the study - Severe kidney dysfunction (eGFR <30 mL/min) - Thrombocytopenia (<50,000/mm3), or neutropenia (absolute neutrophil count <1,500/mm3) - Refusal by a woman of childbearing potential (not post-menopausal or surgically sterile) to use a medically acceptable form of birth control (including, but not limited to, a diaphragm, an intrauterine device (IUD), progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom) throughout the duration of the study - History of hypersensitivity to anakinra or E. coli products - Latex or rubber allergy - Inability to give informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median Interval Change From Baseline in Peak VO2 | Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask. | 28 days | |
Primary | Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) | VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask. | 28 days | |
Secondary | Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide) | 28 days | ||
Secondary | Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI) | 28 days | ||
Secondary | Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2 | 28 days | ||
Secondary | Rate of Adverse Events and Hospitalizations | 28 days | ||
Secondary | Total Exercise Time | 28 days | ||
Secondary | Oxygen Uptake Efficiency Slope | 28 days |
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