NCT05177822Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 14 Dec 2021
- Start date
- 24 May 2022
- Primary completion date
- 22 Feb 2027
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Heart failure
- NCT number
- NCT05177822
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 84
- From 24 May 2022 to the primary completion date, 22 Feb 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to treatment with anakinra (i.e. prior allergic reaction to Kineret® or E. coli derived products);
Other illness
- 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).
- Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent from complying with study instructions;
Lab values
- History of prior STEMI or of systolic heart failure (LVEF\<40%);
- 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);
Other
- Subjects will not be eligible if they meet any of the following exclusion criteria.
- Pregnancy;
- Inability to obtain consent from patient;
- 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);
- Neutropenia (\<1,500/mm3 or \<1,000/mm3 in African-American patients).
- 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.
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.