RecruitingPhase 2NCT05177822

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure: The Virginia - Anakinra Remodeling Trial 4


Sponsor

Virginia Commonwealth University

Enrollment

84 participants

Start Date

May 24, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Patients who have a heart attack are at high risk for future development of heart failure ('weakening of the heart'). The researchers believe that the reaction of the heart muscle to injury (inflammation) during a heart attack may be contributing to the risk of heart failure. The current study will test the ability of an anti-inflammatory medicine (anakinra) to block the inflammation in the body during and after a heart attack.


Eligibility

Min Age: 21 Years

Inclusion Criteria16

  • All criteria need to be met.
  • Acute ST segment elevation myocardial infarction defined as:
  • chest pain, consistent with angina, within the prior 12 hours (for intermittent pain lasting more than 12 hours, the time from the when the pain became severe and constant);
  • ST segment elevation on ECG \>1 mm in 2 or more anatomically contiguous leads;
  • Reperfusion strategy planned or completed (including percutaneous coronary intervention or fibrinolysis)
  • Age \>21 years.
  • Failed reperfusion strategy (unsuccessful percutaneous coronary intervention);
  • Need or plan for emergent cardiac surgery;
  • Anticipated inability to complete a cardiopulmonary exercise test (CPET) on a treadmill at follow up visit at 42 days (i.e. amputee, wheel-chair bound, severe non-cardiac illness limiting mobility).
  • Active infection (such as acute, i.e. COVID-19, or chronic/recurrent infectious disease i.e HBV, HCV, and HIV/AIDS-but excluding HCV+ patients with undetectable plasma RNA)
  • Acute or chronic inflammatory disease or immunosuppressive therapies (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs).
  • Neutropenia (\<1,500/mm3 or \<1,000/mm3 in African-American patients).
  • Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent from complying with study instructions;
  • Stage V chronic kidney disease (estimated glomerular filtration rate 15 mL/min/1.73m2 or less) or on renal-replacement therapy (a GFR ≥45 mL/min/1.73m2 is required for the cardiac magnetic resonance portion of the study);
  • Limited English Proficiency that in the opinion of the investigator may prevent from understanding the content of the informed consent form and instructions during the tests required for the study.
  • Any comorbidity limiting survival or ability to complete the study.

Exclusion Criteria4

  • Pregnancy;
  • Inability to obtain consent from patient;
  • History of prior STEMI or of systolic heart failure (LVEF\<40%);
  • Contraindications to treatment with anakinra (i.e. prior allergic reaction to Kineret® or E. coli derived products);

Interventions

DRUGAnakinra

Anakinra 100 mg/0.67 mL daily subcutaneous injection for up to 14 days, including up to 9 days outpatient treatment;

OTHERPlacebo

0.9% NaCl/0.67 mL daily subcutaneous injection for up to 14 days, including up to 9 days outpatient treatment.


Locations(2)

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

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NCT05177822


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