Can a 14-Day Anti-Inflammatory shot stop heart failure after a heart attack?
NCT ID NCT05177822
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a drug called anakinra, which reduces inflammation, can help prevent heart failure in people who have just had a heart attack. About 84 participants will receive daily injections of anakinra or a placebo for up to 14 days. The goal is to see if blocking inflammation improves heart function and exercise capacity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anakinra (Kineret), an anti-inflammatory drug
- What this could lead to
- If it works, this could point toward a new way to prevent heart failure after a heart attack by calming inflammation.
- What could go wrong
- This is a small, early-phase trial with only 84 participants, so results may not apply to everyone. The drug is given for just 14 days, and its long-term benefits are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Virginia
Charlottesville, Virginia, 22908, United States
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Virginia Commonwealth University
Richmond, Virginia, 23298, United States
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