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

Heart Failure Clinical Trial

— Virginia-ART4  

Official title:

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure: The Virginia - Anakinra Remodeling Trial 4

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177822
• Other study ID #: HM20022826
• Secondary ID: R01AG076360
• Status: Recruiting
• Phase: Phase 2
• Start date: May 24, 2022
• Est. completion date: December 2027

Study information

• Verified date: May 2023
• Source: Virginia Commonwealth University
• Contact: Benjamin Van Tassell, PharmD
• Phone: 804-828-4583
• Email: bvantassell[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Aging (NIA), University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen consumption (peak VO2)	Peak VO2 (expressed as % of predicted) will be assess using cardiopulmonary exercise testing (CPET)	6 weeks