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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 1 and 3 of treatment

Awards & highlights

AID-HEART Trial 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.Check my eligibility

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.See study design

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.

AID-HEART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 21 or older and can sign a consent form.

Select...

I have been on a stable heart medication dose without hospital visits in the last month.

AID-HEART Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 1 and 3 of treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity)

Secondary outcome measures

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

Nausea

Urinary tract infection

Hematemesis

Upper GI hemorrhage

Clostridium difficile infection

Hepatic failure

Encephalopathy

C. difficile infection

Respiratory Failure

Peritonitis

Esophageal varices hemorrhage

Tachycardia

Multiple Organ Dysfunction Syndrome (MODS)

Viremia

Baceteremia

100%

80%

60%

40%

20%

Study treatment Arm

Anakinra & Pentoxifylline & Zinc Sulfate

Methylprednisolone

Observational

AID-HEART 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

~2260

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

699 Previous Clinical Trials

22,885,025 Total Patients Enrolled

23 Trials studying Heart Failure

4,755 Patients Enrolled for Heart Failure

Azita TalasazPrincipal InvestigatorVirginia Coomonwealth University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How would you rate the security of Treatment arm for patients?

"Our team at Power rated Treatment arm's safety as a 1, considering that this is merely Phase 1 of the trial and thus there is limited empirical proof for its efficacy or security."

Answered by AI

Are any more individuals being accepted for this clinical investigation currently?

"As per the data available on clinicaltrials.gov, enrollment for this medical study is still open. It was first posted in September 30th 2023 and has been subject to updates as recently as September 25th of the same year."

Answered by AI

How many participants are involved in this clinical research project?

"Affirmative. Data on clinicaltrials.gov shows that this medical study, which was originally listed on September 30th 2023, is actively recruiting participants. The trial requires at least 20 people to be enrolled from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)

2024. "The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06062966.