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Heart Failure, SystolicPhase 2REDHART2NCT03797001

Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2

A Phase 2 study testing Anakinra in people with Heart Failure, Systolic and Inflammation, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

REDHART2 is a randomized, double-blinded, placebo-controlled trial to determine the effects of Anakinra on peak aerobic exercise capacity measured with a cardiopulmonary test after 24 weeks in patients with recently decompensated systolic heart failure and increased systemic inflammation. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Heart Failure, Systolic, Inflammation
What is being tested?
Anakinra
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteUnited States
Study dates
4 Jan 2019to 22 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All 6 criteria need to be met for enrollment of the patient in the study
  • Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below:
  • dyspnea or respiratory distress or tachypnea at rest or with minimal exertion;
  • evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met):
  • pulmonary congestion/edema at physical exam OR chest XRay;
  • plasma BNP levels ≥200 pg/mL;
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  • invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
  • The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction ≤40%) at most recent assessment by any imaging modality (within 12 months).
  • The patient is now clinically stable, euvolemic, and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:
  • absence of dyspnea or pulmonary congestion/distress at rest;
  • absence of pitting edema in the lower extremities, or in any other region;
  • stable hemodynamic parameters (blood pressure, heart rate).
  • The patient is of age ≥21 years old, and is willing and able to provide written informed consent.
  • The patient is willing and able to comply with the protocol (i.e., self-administration, or exercise test).
  • The patient has screening high sensitivity plasma C-reactive protein levels (hsCRP) >2 mg/L.

Who cannot join

  • Subjects will not be eligible if they meet any of the following 15 exclusion criteria.
  • The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
  • Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study 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.
  • Recent (previous 3 months) or planned resynchronization therapy (CRT), or valve surgeries.
  • Previous or planned implantation of left ventricular assist devices or heart transplant.
  • Chronic use of intravenous inotropes.
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  • 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 (i.e. HBV, HCV, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA.
  • Active malignancy - excluding carcinoma in situ [any location] or localized non-melanoma skin cancer.
  • Any comorbidity limiting survival or ability to complete the study.
  • Stage V kidney disease or on renal-replacement therapy.
  • Neutropenia (<1,500/mm3 or <1,000/mm3 in African-American patients).
  • Pregnancy.
  • Angina, hypertension, arrhythmias, electrocardiograph (ECG) changes, or other non-cardiac limitations (i.e., peak respiratory exchange ratio VCO2/VO2 [RER]<1.0, reflecting sub-maximal test) that limit maximum exertion during CPX obtained during the baseline testing.
  • Hypersensitivity to Kineret or to E. coli derived products. 16) Evidence of COVID19 within the last 60 days or recent (21 days) exposure to close personal contact.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: The Effects of Interleukin-1 Blockade On Exercise Capacity In Patients With Recently Decompensated Systolic Heart Failure

REDHART2 is a randomized, double-blinded, placebo-controlled trial to determine the effects of Anakinra on peak aerobic exercise capacity measured with a cardiopulmonary test after 24 weeks in patients with recently decompensated systolic heart failure and increased systemic inflammation.

Read the detailed description

The REDHART2 (REcently Decompensated Heart failure Anakinra Response 2 Trial) study is a phase II clinical trial of anakinra or placebo to determine improvement in aerobic exercise capacity (by measuring maximal oxygen uptake (VO2)) in patients with recently decompensated systolic heart failure (HF). The recently completed pilot REDHART study showed anakinra treatment for 12 weeks led to a significant improvement in peak aerobic exercise capacity, whereas anakinra treatment for 2 weeks did not, and no significant changes were seen in placebo. The REDHART2 study is designed to expand and confirm the beneficial effect of sustained anakinra treatment (24 weeks) on peak VO2, and to explore the potential effect size on hospital readmissions for HF. The rationale of Interleukin-1 (IL-1) blockade with anakinra in heart failure stems from the evidence of a) reduced adverse cardiac remodeling and heart failure in animal models of acute myocardial infarction (AMI); b) reduced incidence of heart failure in patients with ST-segment elevation AMI; c) enhanced IL-1 activity in patients with heart failure, d) quenching of the acute inflammatory response in patients with acute decompensated heart failure, e) direct cardiodepressant effects of IL-1 in animal models, f) improved exercise capacity in pilot studies including patients with stable systolic heart failure, stable diastolic heart failure, and, recently decompensated systolic heart failure in the pilot REDHART study. Patients will be randomized 2:1 to active treatment, such that patients will be twice as likely to receive anakinra versus placebo.

Being tested
Anakinra, Placebo
Keywords
heart failure, inflammation, anakinra, exercise capacity
Medical subject headings
Heart Failure, Systolic, Inflammation, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnakinraDrug

    100 mg subcutaneous injection, daily for 24 weeks

  • PlaceboDrug

    subcutaneous injection, daily for 24 weeks

Study groups in NCT03797001
Study groupRoleWhat they receive
anakinraExperimentalAnakinra subcutaneous injection, 100 mg daily for 24 weeks
Receives: Drug: Anakinra
placeboPlacebo comparatorPlacebo subcutaneous injection, daily for 24 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Peak Oxygen Consumption (VO2)

    changes in peak oxygen consumption (VO2) after 24 weeks of treatment

    Measured: baseline - 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2019
  2. Study start4 Jan 2019
  3. Primary completion22 Jul 2024
  4. Study completion22 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03797001
Sponsor's protocol ID
REDHART2 HM20014686
Acronym
REDHART2
Status last verified
Jul 2025
First submitted
2 Jan 2019
Last updated
6 Aug 2025
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Mahdiani S, Talasaz AH, AlAzzeh O, Van Tassell B, McClay JL. Epigenetic age acceleration is not strongly associated with cardiorespiratory fitness in heart failure: a pilot study. Epigenomics. 2026 Sep 17:1-12. doi: 10.1080/17501911.2026.2732421. Online ahead of print.

    PubMed 42751917

  • Kelly J, Mezzaroma E, Roscioni A, McSkimming C, Mauro A, Narayan P, Golino M, Trankle C, Canada JM, Toldo S, Van Tassell BW, Abbate A. Interleukin-1 Receptor Antagonist Levels in Patients With Heart Failure and Reduced Ejection Fraction Treated With Anakinra. J Cardiovasc Pharmacol. 2026 Aug 1;88(2):166-172. doi: 10.1097/FJC.0000000000001849. Epub 2026 Jul 20.

    PubMed 42455969

  • Van Tassell BW, Golino M, Canada JM, Markley R, Billingsley H, Del Buono MG, Talasaz A, Thomas G, Chiabrando JG, Wohlford G, Dickson V, Kadariya D, Damonte JI, Ho AJ, Sedhai YR, Kontos E, Vecchie A, West JD, Corna G, Medina de Chazal H, Pinel S, Bressi E, Barron A, Dell M, Mbualungu J, Moroni F, Turlington J, Federmann E, Trankle CR, Carbone S, Arena R, Abbate A. Resolution of Systemic Inflammation in Patients With Recently Decompensated Heart Failure With Reduced Ejection Fraction With and Without Interleukin-1 Blockade by Anakinra. Circ Heart Fail. 2026 Mar;19(3):e013546. doi: 10.1161/CIRCHEARTFAILURE.125.013546. Epub 2025 Dec 23.

    PubMed 41431894

  • Van Tassell B, Mihalick V, Thomas G, Marawan A, Talasaz AH, Lu J, Kang L, Ladd A, Damonte JI, Dixon DL, Markley R, Turlington J, Federmann E, Del Buono MG, Biondi-Zoccai G, Canada JM, Arena R, Abbate A. Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study. J Transl Med. 2022 Jun 15;20(1):270. doi: 10.1186/s12967-022-03466-9.

    PubMed 35706006

  • Sedhai YR, Patel NK, Mihalick V, Talasaz A, Thomas G, Denlinger BL, Damonte JI, Del Buono MG, Federmann E, Hardin M, Ibe I, Harmon M, Van Tassell B, Abbate A. Heart failure clinical trial enrollment at a rural satellite hospital. Contemp Clin Trials. 2022 Apr;115:106731. doi: 10.1016/j.cct.2022.106731. Epub 2022 Mar 11.

    PubMed 35283262

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anakinra in people with Heart Failure, Systolic and Inflammation, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Peak Oxygen Consumption (VO2) (time frame: baseline - 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03797001, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

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