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

NCT05177822 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HM20022826R01AG076360
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (peak VO2)

  Peak VO2 (expressed as % of predicted) will be assess using cardiopulmonary exercise testing (CPET)

  6 weeks

Study Arms (2)

anakinra

EXPERIMENTAL

Drug: Anakinra

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Anakinra DRUG

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

Also known as: Kineret

anakinra

Placebo OTHER

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

placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• University of Virginia: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Benjamin Van Tassell, PharmD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 5, 2022
• Study Start: May 24, 2022
• Primary Completion (Estimated): February 22, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)