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

NCT ID: NCT05177822

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-24
• Study Completion Date: 2027-12-30

Brief 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.

Detailed Description

Anakinra (Kineret®) is a 'copy' of a naturally occurring protein made by the body to block inflammation. The US Food and Drug Administration (FDA) has approved anakinra 100 mg daily for the treatment of rheumatoid arthritis but anakinra is not currently approved for the treatment of heart disease. Anakinra is generally well-tolerated, but can cause pain or redness at the injection site and may affect risk of infections. The study team will work with participants to help avoid (or manage) any side effects throughout the study.

The study is designed to measure how well anakinra can protect participants from developing heart failure. Participation in this study will last approximately 1 year. During the first 2 weeks of the study, participants will receive an injection with anakinra or placebo (a liquid that looks like anakinra but contains no active medicine). While hospitalized, a nurse will do the injections for participants; upon discharge participants will be taught to give the remaining injections at home. Assignment to treatment with anakinra or placebo will be determined by randomization (like the "flip of a coin"). Approximately 84 people will participate in this study over the course of 4 years.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

anakinra

Group Type: EXPERIMENTAL

Anakinra

Intervention Type: DRUG

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

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Anakinra

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Kineret

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.

• 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 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);

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Van Tassell, PharmD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Benjamin Van Tassell, PharmD

Role: CONTACT

bvantassell@vcu.edu

804-828-4583

Facility Contacts

Linda Bryceland, RN, CCRC

Role: primary

lgs2m@virginia.edu

434-982-1058

Benjamin Van Tassell, PharmD

Role: primary

bvantassell@vcu.edu

804-828-4583

Other Identifiers

R01AG076360

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20022826

Identifier Type: -

Identifier Source: org_study_id