Trial Outcomes & Findings for Interleukin-1 Blockade in Recently Decompensated Heart Failure (NCT NCT01936909)
NCT ID: NCT01936909
Last Updated: 2017-12-22
Results Overview
Interval changes in peak oxygen consumption (VO2) after 2 weeks of anakinra treatment.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Baseline to 2 weeks
Results posted on
2017-12-22
Participant Flow
Participant milestones
| Measure |
Anakinra (Short)
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
|
Anakinra (Long)
Anakinra 100 mg daily for 12 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
Anakinra (weeks 3-12)
|
Placebo
Placebo injections daily for 12 weeks
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
10
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interleukin-1 Blockade in Recently Decompensated Heart Failure
Baseline characteristics by cohort
| Measure |
Anakinra (Short)
n=20 Participants
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
|
Anakinra (Long)
n=20 Participants
Anakinra 100 mg daily for 12 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
Anakinra (weeks 3-12)
|
Placebo
n=20 Participants
Placebo injections daily for 12 weeks
Placebo
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
48 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Age, Continuous
|
55 years
n=93 Participants
|
53.5 years
n=4 Participants
|
59.5 years
n=27 Participants
|
56.5 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
20 participants
n=27 Participants
|
60 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 weeksPopulation: Patients who completed baseline and 2 week exercise evaluation
Interval changes in peak oxygen consumption (VO2) after 2 weeks of anakinra treatment.
Outcome measures
| Measure |
Anakinra (Long)
n=18 Participants
Anakinra 100 mg daily for 12 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
Anakinra (weeks 3-12)
|
Placebo
n=18 Participants
Placebo injections daily for 12 weeks
Placebo
|
Anakinra (Short)
n=16 Participants
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
|
|---|---|---|---|
|
Interval Changes in Peak Oxygen Consumption (VO2)
2 weeks
|
14.45 mL/kg/min
Interval 11.075 to 17.725
|
12.65 mL/kg/min
Interval 11.575 to 17.025
|
14.85 mL/kg/min
Interval 12.525 to 16.375
|
|
Interval Changes in Peak Oxygen Consumption (VO2)
Baseline
|
14.45 mL/kg/min
Interval 11.075 to 16.575
|
13.3 mL/kg/min
Interval 11.975 to 15.3
|
14.05 mL/kg/min
Interval 11.225 to 16.15
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients with baseline and follow-up data
The Duke Activity Status Index questionnaire will be completed at enrollment and 12 weeks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores represent increased ability to perform daily activities and may be interpreted as improved quality of life.
Outcome measures
| Measure |
Anakinra (Long)
n=18 Participants
Anakinra 100 mg daily for 12 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
Anakinra (weeks 3-12)
|
Placebo
n=18 Participants
Placebo injections daily for 12 weeks
Placebo
|
Anakinra (Short)
n=16 Participants
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
|
|---|---|---|---|
|
Quality of Life Improvement
Baseline
|
23.45 units on a scale
Interval 15.075 to 38.6125
|
22.825 units on a scale
Interval 12.7625 to 40.075
|
26.95 units on a scale
Interval 17.325 to 47.2
|
|
Quality of Life Improvement
12 weeks
|
34.45 units on a scale
Interval 18.2 to 54.2625
|
28.7 units on a scale
Interval 18.2625 to 37.45
|
37.575 units on a scale
Interval 23.6375 to 50.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All analyses were restricted to patients with a minimum of 2 weeks follow-up.
We will monitor survival and hospitalization for heart failure throughout the 24 week follow-up
Outcome measures
| Measure |
Anakinra (Long)
n=18 Participants
Anakinra 100 mg daily for 12 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
Anakinra (weeks 3-12)
|
Placebo
n=18 Participants
Placebo injections daily for 12 weeks
Placebo
|
Anakinra (Short)
n=16 Participants
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
|
|---|---|---|---|
|
Death or Hospital Admission for Heart Failure
|
1 participants
|
3 participants
|
4 participants
|
Adverse Events
Anakinra (Short)
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Anakinra (Long)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Anakinra (Short)
n=16 participants at risk
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
|
Anakinra (Long)
n=18 participants at risk
Anakinra 100 mg daily for 12 weeks
Anakinra (weeks 1-2): Anakinra 100 mg daily for weeks 1 and 2
Anakinra (weeks 3-12)
|
Placebo
n=18 participants at risk
Placebo injections daily for 12 weeks
Placebo
|
|---|---|---|---|
|
Cardiac disorders
Death
|
6.2%
1/16 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
0.00%
0/18
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
5.6%
1/18 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
|
Cardiac disorders
Cardiac arrhythmia
|
6.2%
1/16 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
5.6%
1/18 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
11.1%
2/18 • Number of events 2
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
|
Nervous system disorders
Stroke
|
6.2%
1/16 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
5.6%
1/18 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
5.6%
1/18 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
|
Infections and infestations
Serious infection
|
6.2%
1/16 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
5.6%
1/18 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
11.1%
2/18 • Number of events 2
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
18.8%
3/16 • Number of events 3
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
0.00%
0/18
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
5.6%
1/18 • Number of events 1
All analyses were restricted to patients with a minimum of 2 weeks follow-up.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place