Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2

NCT03797001 | Completed Phase 2 Results FDA Drug

• 1 other identifier: REDHART2 HM20014686
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure, Systolic; Inflammation

Keywords

heart failure; inflammation; anakinra; exercise capacity

Outcome Measures

Primary Outcomes (1)

• Changes in Peak Oxygen Consumption (VO2)

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

  baseline - 24 weeks

Study Arms (2)

anakinra

EXPERIMENTAL

Anakinra subcutaneous injection, 100 mg daily for 24 weeks

Drug: Anakinra

placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection, daily for 24 weeks

Drug: Placebo

Interventions

Anakinra DRUG

100 mg subcutaneous injection, daily for 24 weeks

anakinra

Placebo DRUG

subcutaneous injection, daily for 24 weeks

placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

• Van Tassell BW, Golino M, Canada JM, Markley R, Billingsley H, Del Buono M, 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 C, 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. 2025 Dec 23:e013546. doi: 10.1161/CIRCHEARTFAILURE.125.013546. Online ahead of print.

  PMID: 41431894 DERIVED

• 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.

  PMID: 35706006 DERIVED

• 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.

  PMID: 35283262 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic; Inflammation; Heart Failure

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Benjamin Van Tassell
• Organization: Virginia Commonwealth University

bvantassell@vcu.edu

8048284583

Study Officials

• Benjamin Van Tassell, PharmD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 8, 2019
• Study Start: January 4, 2019
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Locations

US (1)