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

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Acute onset 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

Exclusion Criteria:

• Age<21 years;

• 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 (continuously - see exceptions in Inclusion Criteria);

• Need for emergent cardiac surgery;

• Active infection (of any type), including chronic/recurrent infectious disease (including 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;

• Any comorbidity limiting survival or ability to complete the study.

• Stage V chronic kidney disease (estimated glomerular filtration rate 15 mL/min or less) or on renal-replacement therapy.

• 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.

• Inability to complete CPET.