Status:
RECRUITING
The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
Heart failure (HF) represents a leading cause of morbidity and mortality worldwide. Despite improvements in treatments and widespread efforts to implement guideline directed medical therapies, a growi...
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
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06062966
Start Date
February 5 2024
End Date
June 1 2026
Last Update
November 17 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23284