Actively Recruiting

Phase 1
Age: 21Years +
All Genders
NCT06062966

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

Led by Virginia Commonwealth University · Updated on 2025-11-17

20

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary diagnosis is stage D heart failure with chronic stable inotrope therapy (dobutamine or milrinone) for at least 28 days
  • Left ventricular ejection fraction less than 50% within the past 12 months
  • Stable inotrope dose without hospitalization in the previous month
  • Age 21 years or older and able to provide written informed consent
  • Willing and able to follow the study protocol including self-administration of treatment and exercise
  • Screening plasma C-reactive protein level greater than 2 mg/L
Not Eligible

You will not qualify if you...

  • Significant other health problems such as acute coronary syndromes, uncontrolled blood pressure issues, arrhythmias, lung or neuromuscular diseases affecting breathing
  • Recent or planned heart resynchronization therapy or valve surgery within 3 months
  • Previous or planned left ventricular assist device or heart transplant within 3 months
  • Use of immunosuppressive or anti-inflammatory drugs in past 14 days, excluding low dose corticosteroids or NSAIDs
  • Chronic inflammatory diseases like rheumatoid arthritis or lupus
  • Active infections including chronic or recurrent infections except undetectable HCV RNA
  • Cancer treatment within past 5 years except localized skin cancers or carcinoma in situ
  • Severe kidney disease or on dialysis
  • Low neutrophil counts
  • Pregnancy or breastfeeding
  • Heart-related conditions limiting exercise test results
  • Allergy to anakinra or related products

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Virginia Commonwealth University

Richmond, Virginia, United States, 23284

Actively Recruiting

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Research Team

B

Benjamin VanTassell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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