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Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03797001
Acronym
REDHART2
Enrollment
102
Registered
2019-01-08
Start date
2019-01-04
Completion date
2024-07-22
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Systolic, Inflammation

Keywords

heart failure, inflammation, anakinra, exercise capacity

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.

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.

Interventions

DRUGAnakinra

100 mg subcutaneous injection, daily for 24 weeks

DRUGPlacebo

subcutaneous injection, daily for 24 weeks

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All 6 criteria need to be met for enrollment of the patient in the study 1. 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. 2. 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). 3. 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). 4. The patient is of age ≥21 years old, and is willing and able to provide written informed consent. 5. The patient is willing and able to comply with the protocol (i.e., self-administration, or exercise test). 6. The patient has screening high sensitivity plasma C-reactive protein levels (hsCRP) \>2 mg/L.

Exclusion criteria

Subjects will not be eligible if they meet any of the following 15

Design outcomes

Primary

MeasureTime frameDescription
Changes in Peak Oxygen Consumption (VO2)baseline - 24 weekschanges in peak oxygen consumption (VO2) after 24 weeks of treatment

Countries

United States

Participant flow

Participants by arm

ArmCount
Anakinra
Anakinra subcutaneous injection, 100 mg daily for 24 weeks Anakinra: 100 mg subcutaneous injection, daily for 24 weeks
68
Placebo
Placebo subcutaneous injection, daily for 24 weeks Placebo: subcutaneous injection, daily for 24 weeks
34
Total102

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event01
Overall StudyWithdrawal by Subject76
Overall StudyWithdrawn due to COVID1940

Baseline characteristics

CharacteristicPlaceboTotalAnakinra
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants28 Participants17 Participants
Age, Categorical
Between 18 and 65 years
23 Participants74 Participants51 Participants
Age, Continuous58 years58 years58 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
28 Participants75 Participants47 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
6 Participants25 Participants19 Participants
Region of Enrollment
United States
34 participants102 participants68 participants
Sex: Female, Male
Female
26 Participants66 Participants40 Participants
Sex: Female, Male
Male
8 Participants36 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 681 / 34
other
Total, other adverse events
11 / 687 / 34
serious
Total, serious adverse events
12 / 686 / 34

Outcome results

Primary

Changes in Peak Oxygen Consumption (VO2)

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

Time frame: baseline - 24 weeks

Population: patients with data available for primary outcome analysis

ArmMeasureValue (MEDIAN)
AnakinraChanges in Peak Oxygen Consumption (VO2)1.50 mL/kg/min
PlaceboChanges in Peak Oxygen Consumption (VO2)1.20 mL/kg/min
p-value: 0.6t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026