RecruitingPhase 1NCT06062966

The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)

Sponsor

Virginia Commonwealth University

Enrollment

20 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether an IL-1 blocker (a drug that reduces a specific type of inflammation) can improve the response to inotrope therapy — medications that help a weakened heart pump stronger — in patients with advanced heart failure who are already on continuous inotrope infusions. **You may be eligible if...** - Your primary diagnosis is advanced (Stage D) heart failure - You are currently receiving a stable, continuous infusion of an inotrope (dobutamine or milrinone) for at least 28 days - Your heart pumping function (ejection fraction) is less than 50%, confirmed within the last 12 months - You are 21 or older and can provide written informed consent **You may NOT be eligible if...** - You have been hospitalized in the past month - Your inotrope dose has not been stable - You have active infections or other conditions incompatible with IL-1 blockade Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnakinra

Anakinra 100 mg SC daily will be administered to sujects on chronic inotrope treatment who are not candidates for transplantation or left ventricular assist device (LVAD).

Locations(1)

Virginia Commonwealth University

Richmond, Virginia, United States

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NCT06062966

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