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Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure (Virginia-ART4)

Primary Purpose

Heart Failure

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Anakinra

Placebo

About this trial

This is an interventional prevention trial for Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of VirginiaRecruiting
Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

anakinra

placebo

Arm Description

Outcomes

Primary Outcome Measures

Peak oxygen consumption (peak VO2)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05177822

First Posted

December 14, 2021

Last Updated

May 1, 2023

Sponsor

Virginia Commonwealth University

Collaborators

National Institute on Aging (NIA), University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT05177822

Brief Title

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

Acronym

Virginia-ART4

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 24, 2022 (Actual)

Primary Completion Date

February 2027 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

Collaborators

National Institute on Aging (NIA), University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

anakinra

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Anakinra

Other Intervention Name(s)

Kineret

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Peak oxygen consumption (peak VO2)

Description

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Benjamin Van Tassell, PharmD

Phone

804-828-4583

bvantassell@vcu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Van Tassell, PharmD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Bryceland, RN, CCRC

Phone

434-982-1058

lgs2m@virginia.edu

First Name & Middle Initial & Last Name & Degree

Antonio Abbate, MD

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benjamin Van Tassell, PharmD

Phone

804-828-4583

bvantassell@vcu.edu

First Name & Middle Initial & Last Name & Degree

Benjamin Van Tassell, PharmD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

A simplified and fully de-identified database will be made available for sharing in accordance with requirements for National Institute on Aging (NIA) data repository datasets and associated documentation for submission to the Biological Specimen and Data Repository Information Coordinating Center (BioLINCC) and the NIA Guidance on Sharing Data and other Resources, within 3 years of completion of the study.

Learn more about this trial

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

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