Heart failure hope: Anti-Inflammatory drug may reduce need for dangerous heart meds
NCT ID NCT06062966
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This early-phase study tests whether anakinra, a drug that blocks inflammation, can make the heart more sensitive to inotropes (medicines that strengthen heart contractions) in people with end-stage heart failure. If successful, patients might need lower, safer doses of inotropes. The study involves 20 adults on stable inotrope therapy and will measure changes in inflammation and medication needs over 3 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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4 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Virginia Commonwealth University
Richmond, Virginia, 23284, United States
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Other studies related to the condition(s) this trial covers.
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