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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT03057028
Collaborator
(none)
7
Enrollment
1
Location
1
Arm
26.2
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open label treatment with AnakinraOpen 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 :
Apr 1, 2016
Actual Primary Completion Date :
Jun 7, 2018
Actual Study Completion Date :
Jun 7, 2018

Arms and Interventions

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 Names:
  • Kineret

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in exercise capacity, as determined by peak oxygen consumption and ventilatory efficiency on cardiopulmonary exercise testing [14 days]

    Secondary Outcome Measures

    1. Effect of anakinra on serum high sensitivity C-reactive protein [14 days]

    2. Effect of anakinra on serum NT-pro-BNP. [14 days]

    3. Effect of anakinra on serum interleukin-6 [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). [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) [14 days]

    6. Number of patients with treatment related adverse events related to anakinra in patients with pulmonary arterial hypertension [14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University

    Investigators

    • Principal Investigator: Dan Grinnan, MD, Virginia Commonwealth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT03057028
    Other Study ID Numbers:
    • HM20005870
    First Posted:
    Feb 17, 2017
    Last Update Posted:
    Apr 5, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Pulmonary Arterial Hypertension
    Familial Primary Pulmonary Hypertension
    Hypertension
    Interleukin 1 Receptor Antagonist Protein

    Study Results

    No Results Posted as of Apr 5, 2019