Blocking inflammation to prevent heart failure after a heart attack

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

This study is testing if an anti-inflammatory medication called anakinra can help people who have had a heart attack avoid heart failure.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Virginia Commonwealth University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 2 sites (Charlottesville, Virginia and 1 other locations)
• Trial ID: NCT05177822 on ClinicalTrials.gov

What this trial studies

This study investigates the use of anakinra, an anti-inflammatory medication, to reduce the risk of heart failure in patients who have experienced an acute myocardial infarction. Participants will receive either anakinra or a placebo for two weeks while hospitalized, followed by self-administered injections at home for a year. The study aims to determine if reducing inflammation during and after a heart attack can protect the heart muscle and prevent future heart failure. Approximately 84 participants will be enrolled over four years, with randomization to ensure unbiased treatment assignment.

Who should consider this trial

Good fit: Ideal candidates are adults over 21 who have experienced an acute ST segment elevation myocardial infarction within the last 12 hours.

Not a fit: Patients with a history of prior heart attacks or those with systolic heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of heart failure in patients recovering from heart attacks.

How similar studies have performed: While the use of anakinra for heart disease is novel, similar anti-inflammatory approaches have shown promise in other cardiovascular conditions.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Subjects will not be eligible if they meet any of the following exclusion criteria.

* 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);
* Duration of chest pain \>12 hours at time of coronary artery catheterization (continuously - see exceptions in Inclusion Criteria) or coronary artery intervention \>12 hours earlier (see exceptions in Inclusion Criteria)\[max duration of chest pain 24 hours\];
* 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.

Where this trial is running

Charlottesville, Virginia and 1 other locations

• University of Virginia — Charlottesville, Virginia, United States (Recruiting)
• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Benjamin Van Tassell, PharmD — Virginia Commonwealth University
• Study coordinator: Benjamin Van Tassell, PharmD

Conditions Heart Failure