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Anakinra / Heart Failure · Phase 1 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 1 trial registration for anakinra in end-stage heart failure, designed to measure IL-1 blockade via hsCRP reduction over 3 months. No results are posted in this registry record, so the efficacy, safety, or clinical benefit of the intervention cannot be evaluated from this source.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Heart Failure; age from 21 Years. Intervention: Treatment arm. n = 4. 1 site: United States.
This is a completed Phase 1 trial registration for anakinra in end-stage heart failure, designed to measure IL-1 blockade via hsCRP reduction over 3 months. No results are posted in this registry record, so the efficacy, safety, or clinical benefit of the intervention cannot be evaluated from this source.
Primary endpoint is biomarker reduction (hsCRP), not clinical outcomes such as inotrope reduction, mortality, or symptom relief.
This early-phase trial addresses the clinical need to reduce inotrope exposure in refractory heart failure, but results are not yet available in this registry record. Clinicians should not make treatment decisions based on this registration alone and must await publication of results.
Phase 1 study with very small enrollment (n=4) measuring a biomarker endpoint; no results posted in this registry record, so evidence strength cannot be determined.
As stated by the source record.
Quoted from the source exactly as published.
This early-phase trial addresses the clinical need to reduce inotrope exposure in refractory heart failure, but results are not yet available in this registry record. Clinicians should not make treatment decisions based on this registration alone and must await publication of results.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06062966). This is a study registration, not published results. Lead sponsor: Virginia Commonwealth University. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 4 participants (ACTUAL). Conditions: Heart Failure. Interventions: DRUG: Anakinra. Primary outcome measures: Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity) , Months 1 and 3 of treatment. Brief summary: End-stage heart failure (HF) is a progressive illness with a mortality rate similar to most advanced cancers.Roughly 5% of patients with HF have end-stage disease that is refractory to medical therapy (stage D heart failure). When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, or elect a palliative approach, inotropes are frequently used to improve hemodynamics through an increase in cardiac output and reduction in filling pressures. While inotropes provide profound symptomatic relief, these benefits are accompanied by significant risks of progressive adverse cardiac remodeling, arrhythmias, and sudden death. There is, therefore, an urgent need to develop strategies to reduce the dose or duration of inotrope use in the management of patients with stage D of HF.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.