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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Primary diagnosis for the clinic visit is stage D heart failure being on chronic stable dose of inotrope therapy (dobutamine or milrinone for the previous 28 days)

• Prior documentation of impaired left ventricular systolic function (ejection fraction \<50%) at most recent assessment by any imaging modality (within 12 months)

• Stable dose of inotrope treatment without a recent hospitalization within the previous month

• Age ≥21 years and willing/able to provide written informed consent

• The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).

• Screening plasma C-reactive protein levels \>2 mg/L

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Benjamin VanTassell
bvantassell@vcu.edu
8048284583
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2025-10
Participants
Target number of participants: 20
Treatments
Experimental: Treatment arm
Related Therapeutic Areas
Sponsors
Leads: Virginia Commonwealth University

This content was sourced from clinicaltrials.gov