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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06062966
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anakinra — DRUG
    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).

Study Details

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.

Key Dates

Start date
Feb 5, 2024
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm

Primary Outcome Measure

Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity) [ Time Frame: Months 1 and 3 of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23284
Azita Talasazah
804-828-4583
Benjamin Van Tassell
8048284583

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