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Cytokine Inhibitor

Anakinra for Heart Failure (AID-HEART Trial)

Phase 1
Recruiting
Led By Azita Talasaz
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥21 years and willing/able to provide written informed consent
Stable dose of inotrope treatment without a recent hospitalization within the previous month
Must not have
Concomitant clinically significant comorbidities including 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
Stage V kidney disease or on renal-replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1 and 3 of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at end-stage heart failure, a severe form of the illness. Treatments can prolong life, but come with risks. Researchers want to develop strategies to reduce the need for these treatments. #HeartFailure #Treatments

Who is the study for?
This trial is for adults over 21 with stage D heart failure who have been on a stable inotrope dose without hospitalization for the past month. They must be able to self-administer treatment and follow the protocol, with an ejection fraction <50% and C-reactive protein levels >2 mg/L. Excluded are those with chronic inflammation, pregnancy, neutropenia, significant comorbidities that affect study participation, recent or planned heart surgeries or devices, immunosuppressive drug use, active infections including certain viruses but not HCV with undetectable RNA, current malignancies except certain skin cancers or carcinoma in situ.
What is being tested?
The AID-HEART trial tests Anakinra's effect on reducing the need for inotropes which increase cardiac output but carry risks like adverse cardiac remodeling and arrhythmias. The goal is to improve management of patients with end-stage heart failure by potentially lowering doses or duration of inotrope therapy.
What are the potential side effects?
Anakinra may cause allergic reactions due to its E. coli origin; it can also lead to infection risks because it affects immune response. Other side effects might include changes related to blood pressure (like hypotension), disturbances in heartbeat rhythms (arrhythmias), and potential hypersensitivity issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 or older and can sign a consent form.
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I have been on a stable heart medication dose without hospital visits in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious health issues that could affect my participation in the study.
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I have advanced kidney disease or am on dialysis.
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I have had cancer treatment in the last 5 years, but not for early-stage skin cancer or carcinoma in situ.
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I have a chronic inflammatory disorder like rheumatoid arthritis or lupus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1 and 3 of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1 and 3 of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity)
Secondary study objectives
Change in exercise capacity will be measured with a 6-minute walk test (6MWT)
Change of inotrope dose (over 24 hrs) as a percentage of baseline inotrope dose (over 24 hrs)

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment armExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
2016
Completed Phase 4
~1320

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
716 Previous Clinical Trials
22,888,478 Total Patients Enrolled
25 Trials studying Heart Failure
4,782 Patients Enrolled for Heart Failure
Azita TalasazPrincipal InvestigatorVirginia Coomonwealth University
~5 spots leftby Mar 2025
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