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

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ClinicalTrials.gov Identifier: NCT03057028
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Anakinra Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label treatment with Anakinra
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension
Study Start Date : April 2016
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : June 7, 2018


Arm Intervention/treatment
Experimental: anakinra
Patients will be treated with anakinra, injected SQ daily in a dose of 100mg for 14 days. Before and after this intervention, patients will undergo cardiopulmonary exercise testing (as well as echocardiography, EKG analysis, and serologic analysis). Subjects will be assessed for changes in exercise capacity, as determined by peak oxygen uptake and ventilatory efficiency to CO2 production slope.
Drug: Anakinra
Other Name: Kineret




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

Secondary Outcome Measures :
  1. Effect of anakinra on serum high sensitivity C-reactive protein [ Time Frame: 14 days ]
  2. Effect of anakinra on serum NT-pro-BNP. [ Time Frame: 14 days ]
  3. Effect of anakinra on serum interleukin-6 [ Time Frame: 14 days ]
  4. 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 ]
  5. 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 ]
  6. Number of patients with treatment related adverse events related to anakinra in patients with pulmonary arterial hypertension [ Time Frame: 14 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057028


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Dan Grinnan, MD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03057028    
Other Study ID Numbers: HM20005870
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents