Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure (VA-ART4)
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ClinicalTrials.gov Identifier: NCT05177822 |
Recruitment Status :
Recruiting
First Posted : January 5, 2022
Last Update Posted : May 3, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | December 14, 2021 | ||||||
First Posted Date ICMJE | January 5, 2022 | ||||||
Last Update Posted Date | May 3, 2024 | ||||||
Actual Study Start Date ICMJE | May 24, 2022 | ||||||
Estimated Primary Completion Date | February 2027 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Peak oxygen consumption (peak VO2) [ Time Frame: 6 weeks ] Peak VO2 (expressed as % of predicted) will be assess using cardiopulmonary exercise testing (CPET)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure | ||||||
Official Title ICMJE | Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure: The Virginia - Anakinra Remodeling Trial 4 | ||||||
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Heart Failure | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
84 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 2027 | ||||||
Estimated Primary Completion Date | February 2027 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: All criteria need to be met.
Exclusion Criteria: Subjects will not be eligible if they meet any of the following exclusion criteria.
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05177822 | ||||||
Other Study ID Numbers ICMJE | HM20022826 R01AG076360 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Virginia Commonwealth University | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Virginia Commonwealth University | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Virginia Commonwealth University | ||||||
Verification Date | May 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |