Effects of IL-1 Blockade on Heart Failure Treatment
The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)
This study is testing if a medication that reduces inflammation can help people with severe heart failure feel better and improve their heart function while they are on other heart medications.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06062966 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of IL-1 blockade using Anakinra on inotrope sensitivity in patients with end-stage heart failure. The study focuses on patients who are on stable doses of inotropes and aims to determine if reducing the inflammatory response can improve their cardiac function and reduce the risks associated with inotrope therapy. By targeting inflammation, the trial seeks to enhance the effectiveness of current treatments and potentially improve patient outcomes. Participants will self-administer the treatment and follow an exercise protocol as part of the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with stage D heart failure who have been on a stable dose of inotropes for at least 28 days.
Not a fit: Patients with significant comorbidities or those not on stable inotrope therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective management of heart failure, reducing the need for high doses of inotropes.
How similar studies have performed: While the approach of targeting IL-1 in heart failure is promising, it remains novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Azita Talasaz — Virginia Coomonwealth University
- Study coordinator: Benjamin VanTassell
- Email: bvantassell@vcu.edu
- Phone: 8048284583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.