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New treatment option for Heart Failure
Official title The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)
ClinicalTrials.gov ID: NCT06062966
What this study is testing
What is Anakinra?
Anakinra is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join 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...
- Prior documentation of impaired left ventricular systolic function (ejection fraction \<50%) at most recent assessment by any imaging modality...
- 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).
You likely can't join if
- Concomitant clinically significant comorbidities including (but not limited to) acute coronary syndromes, uncontrolled hypertension or orthostatic...
- 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...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.