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Anakinra for Heart Failure Patients on Inotropes

This study is looking at how a drug called Anakinra might help people with advanced heart failure who are already receiving chronic inotrope treatment (like dobutamine or milrinone). Inotropes are medicines that strengthen heart contractions, but they can have side effects. Anakinra works by blocking a protein called IL-1, which is linked to inflammation in heart failure. The study aims to see if Anakinra can reduce inflammation, specifically by measuring a marker called hsCRP. You might be able to join if you have stage D heart failure, have been on a stable dose of inotropes for at least 28 days, and have a reduced heart pumping ability (ejection fraction less than 50%). The study plans to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
You would receive Anakinra 100 mg daily under the skin. Your hsCRP levels would be measured at months 1 and 3 of treatment.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for at least 3 months, based on the primary endpoint measurements.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06062966

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

Completed
PHASE1Ages 21+InterventionalTreatment
Virginia Commonwealth University
~4 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:Anakinra

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity)
Measured over Months 1 and 3 of treatment

Conditions

Heart Failure

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NCT06062966

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Virginia Commonwealth University

    Richmond, Virginiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Azita Talasaz · PRINCIPAL_INVESTIGATOR · Virginia Coomonwealth University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

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

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