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

NCT06062966 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HM20027160
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Inotrope sensitivity; IL-1 Blockade; Subcutaneous (SC); Hepatitis B Virus (HBV); Hepatitis C Virus (HCV; 6 Minute Walk Test (6MWT)

Outcome Measures

Primary Outcomes (1)

• Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity)

  Percent reduction in hsCRP (a biomarker for IL-1 activity) at 1 month and 3 months of anakinra treatment.

  Months 1 and 3 of treatment

Secondary Outcomes (2)

• Change of inotrope dose (over 24 hrs) as a percentage of baseline inotrope dose (over 24 hrs)

  Months 1 and 3 of treatment

• Change in exercise capacity will be measured with a 6-minute walk test (6MWT)

  Baseline, Months 1 and 3 of treatment

Study Arms (1)

Treatment arm

EXPERIMENTAL

Drug: Anakinra

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).

Treatment arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concomitant clinically significant comorbidities including (but not limited to) acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration that would interfere with the execution, interpretation, or completion of the study
• Recent (previous 3 months) or planned resynchronization therapy (CRT), or valve surgeries
• Previous or planned implantation of left ventricular assist devices or heart transplant within the next 3 months
• Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs)
• Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
• Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA
• Prior (within the past 5 years) or current malignancy on targeted treatment - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer
• Stage V kidney disease or on renal-replacement therapy
• Neutropenia (\<1,500/mm3 or \<1,000/mm3 in African-American patients)
• Pregnancy or breastfeeding
• Angina, hypertension, arrhythmias, electrocardiograph (ECG) changes, or other non-cardiac limitations that limit 6MWD obtained during the baseline testing
• Hypersensitivity to anakinra or to E. coli derived products

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Hepatitis B; Hepatitis C

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Azita Talasaz

  Virginia Coomonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin VanTassell

CONTACT

8048284583; bvantassell@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot study designed to treat 20 subjects to provide the preliminary data necessary to inform the design of subsequent hypothesis-driven studies.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: February 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)