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Interleukin-1 Blocker
Interleukin-1 Blockade for Recently Decompensated Heart Failure (REDHART2 Trial)
Phase 2
Recruiting
Led By Antonio Abbate, MD, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient is now clinically stable, euvolemic, and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:
The patient is of age ≥21 years old, and is willing and able to provide written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 24 weeks
Awards & highlights
REDHART2 Trial Summary
This trial is testing whether the drug Anakinra can help improve the exercise capacity of patients with heart failure and inflammation.
Who is the study for?
Adults over 21 with recent heart failure hospitalization, stable enough for discharge, and a specific inflammation marker (hsCRP >2 mg/L) can join. They must have had reduced heart function (ejection fraction ≤40%) in the past year. Excluded are those with other serious conditions or treatments that could affect results, like severe kidney disease, immune disorders, infections including COVID-19 within 60 days, pregnancy, or recent use of certain drugs.Check my eligibility
What is being tested?
REDHART2 is testing whether Anakinra improves exercise capacity in patients with systolic heart failure and inflammation after 24 weeks compared to a placebo. It's randomized (participants are put into groups by chance), double-blinded (neither participants nor researchers know who gets what treatment), and placebo-controlled.See study design
What are the potential side effects?
Anakinra may cause reactions at the injection site, increased risk of infections due to its effect on the immune system, headaches, nausea and possibly allergic reactions. The severity of side effects varies from person to person.
REDHART2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am stable, not retaining fluid, and ready to leave the hospital.
Select...
I am 21 or older and can sign a consent form.
Select...
I was hospitalized for worsening heart failure.
REDHART2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline - 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
changes in peak oxygen consumption (VO2)
Secondary outcome measures
Biomarker - N-terminal pro b-type Natriuretic Peptide (NT-proBNP)
Biomarker - high sensitivity C-reactive protein (CRP)
Clinical Outcome - cardiac death
+5 moreSide effects data
From 2018 Phase 2 & 3 trial • 104 Patients • NCT0180913219%
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
REDHART2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: anakinraExperimental Treatment1 Intervention
Anakinra subcutaneous injection, 100 mg daily for 24 weeks
Group II: placeboPlacebo Group1 Intervention
Placebo subcutaneous injection, daily for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
FDA approved
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,884,943 Total Patients Enrolled
23 Trials studying Heart Failure
4,673 Patients Enrolled for Heart Failure
Antonio Abbate, MD, PhDPrincipal InvestigatorVirginia Commonwealth University
13 Previous Clinical Trials
408 Total Patients Enrolled
6 Trials studying Heart Failure
238 Patients Enrolled for Heart Failure
Benjamin Van Tassell, PharmDPrincipal InvestigatorVirginia Commonwealth University
4 Previous Clinical Trials
158 Total Patients Enrolled
2 Trials studying Heart Failure
115 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or will have heart surgery or CRT in the last 3 months.I do not have any major health issues that could affect the study.Your blood doesn't have enough neutrophils, a type of white blood cell.I have a long-term inflammatory condition like rheumatoid arthritis or lupus.You have another illness that could make it hard for you to finish the study.I am stable, not retaining fluid, and ready to leave the hospital.I have heart issues or other conditions that limit my physical exertion.I have had COVID-19 or been exposed to it in the last 21-60 days.My heart's pumping ability is reduced (ejection fraction ≤40%).I do not have any active infections, including chronic diseases like HIV, but HCV is okay if undetectable.Your blood test shows high sensitivity plasma C-reactive protein levels above 2 mg/L.I regularly use medication through an IV to help my heart pump better.I haven't taken strong immune system or inflammation drugs in the last 2 weeks.I am 21 or older and can sign a consent form.My hospital admission was not due to severe heart failure or related heart issues.I was hospitalized for worsening heart failure.I have advanced kidney disease or am on dialysis.You are allergic to Kineret or products derived from E. coli bacteria.You have had or plan to have a device implanted to help your heart, or a heart transplant.I have an active cancer, but it's not a minor skin cancer or a localized pre-cancerous condition.
Research Study Groups:
This trial has the following groups:- Group 1: placebo
- Group 2: anakinra
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what purposes is Anakinra typically given to patients?
"Anakinra is most commonly used as an intervention for systemic juvenile idiopathic arthritis (sjia). It can also be prescribed to treat various conditions such as neonatal-onset multisystem inflammatory disease (nomid), and receptors, interleukin-1, steroids."
Answered by AI
What does the scientific research say about Anakinra's medical efficacy?
"At the moment, there are 34 different ongoing studies that involve Anakinra with 6 of them being in Phase 3. The majority of these clinical trials take place in Paris and its surrounding areas. In total, 440 research sites are conducting these investigations."
Answered by AI
How many people are eligible for this clinical trial?
"Yes, the trial is still looking for patients. According to information on clinicaltrials.gov, the study was originally posted on January 4th, 2019 and was last updated on September 7th, 2022. They are 102 participants needed from 1 site."
Answered by AI
Has Anakinra gained approval from the Federal Drug Administration?
"While there is some data suggesting Anakinra is safe, it lacks the efficacy data of Phase 3 trials and thus receives a score of 2."
Answered by AI
Are people still being accepted to participate in this research?
"That is accurate. The information available on clinicaltrials.gov shows that this trial is currently open for recruitment. This particular study was first published on January 4th, 2019 and updated September 7th, 2020. They are looking for 102 participants at 1 site."
Answered by AI
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