Trial Outcomes & Findings for Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2 (NCT NCT03797001)
NCT ID: NCT03797001
Last Updated: 2025-08-06
Results Overview
changes in peak oxygen consumption (VO2) after 24 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
baseline - 24 weeks
Results posted on
2025-08-06
Participant Flow
Participant milestones
| Measure |
Anakinra
Anakinra subcutaneous injection, 100 mg daily for 24 weeks
Anakinra: 100 mg subcutaneous injection, daily for 24 weeks
|
Placebo
Placebo subcutaneous injection, daily for 24 weeks
Placebo: subcutaneous injection, daily for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
34
|
|
Overall Study
COMPLETED
|
57
|
27
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
| Measure |
Anakinra
Anakinra subcutaneous injection, 100 mg daily for 24 weeks
Anakinra: 100 mg subcutaneous injection, daily for 24 weeks
|
Placebo
Placebo subcutaneous injection, daily for 24 weeks
Placebo: subcutaneous injection, daily for 24 weeks
|
|---|---|---|
|
Overall Study
Withdrawn due to COVID19
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2
Baseline characteristics by cohort
| Measure |
Anakinra
n=68 Participants
Anakinra subcutaneous injection, 100 mg daily for 24 weeks
Anakinra: 100 mg subcutaneous injection, daily for 24 weeks
|
Placebo
n=34 Participants
Placebo subcutaneous injection, daily for 24 weeks
Placebo: subcutaneous injection, daily for 24 weeks
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Continuous
|
58 years
n=99 Participants
|
58 years
n=107 Participants
|
58 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=99 Participants
|
34 participants
n=107 Participants
|
102 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline - 24 weeksPopulation: patients with data available for primary outcome analysis
changes in peak oxygen consumption (VO2) after 24 weeks of treatment
Outcome measures
| Measure |
Anakinra
n=57 Participants
Anakinra subcutaneous injection, 100 mg daily for 24 weeks
Anakinra: 100 mg subcutaneous injection, daily for 24 weeks
|
Placebo
n=27 Participants
Placebo subcutaneous injection, daily for 24 weeks
Placebo: subcutaneous injection, daily for 24 weeks
|
|---|---|---|
|
Changes in Peak Oxygen Consumption (VO2)
|
1.50 mL/kg/min
Interval -0.15 to 3.35
|
1.20 mL/kg/min
Interval 0.5 to 3.9
|
Adverse Events
Anakinra
Serious events: 12 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Anakinra
n=68 participants at risk
Anakinra subcutaneous injection, 100 mg daily for 24 weeks
Anakinra: 100 mg subcutaneous injection, daily for 24 weeks
|
Placebo
n=34 participants at risk
Placebo subcutaneous injection, daily for 24 weeks
Placebo: subcutaneous injection, daily for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/68 • 1 year
|
2.9%
1/34 • 1 year
|
|
Cardiac disorders
Heart failure hospitalization
|
8.8%
6/68 • 1 year
|
8.8%
3/34 • 1 year
|
|
General disorders
Any hospitalization
|
17.6%
12/68 • 1 year
|
17.6%
6/34 • 1 year
|
Other adverse events
| Measure |
Anakinra
n=68 participants at risk
Anakinra subcutaneous injection, 100 mg daily for 24 weeks
Anakinra: 100 mg subcutaneous injection, daily for 24 weeks
|
Placebo
n=34 participants at risk
Placebo subcutaneous injection, daily for 24 weeks
Placebo: subcutaneous injection, daily for 24 weeks
|
|---|---|---|
|
Infections and infestations
Infection requiring antibiotic
|
16.2%
11/68 • 1 year
|
20.6%
7/34 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place