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 — DRUGAnakinra 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
- Benjamin VanTassell8048284583
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23284 |
Find similar trials in Richmond, VA
Related Studies
- Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRecruiting · Medtronic · Birmingham, Alabama
- The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMRRecruiting · Cardiac Dimensions, Inc. · Gilbert, Arizona
- Global Utilization And Registry Database for Improved heArt preservatioNEnrolling By Invitation · Paragonix Technologies · Stanford, California
- Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock TrialRecruiting · Inova Health Care Services · Falls Church, Virginia