Trial Outcomes & Findings for Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Heart Failure (NCT NCT01300650)

Results Overview

Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight. The outcome measure time frame was 14 days. This means that change in peak VO2 was calculated as the difference between peak VO2 at baseline and 14 days. To calculate this change, we used the mathematical process of subtraction (change in peak VO2 = Peak VO2 \[day 14\] - Peak VO2 \[baseline\])

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

14 days

Results posted on

2017-11-30

Participant Flow

11 patients had elevated hsCRP (\>2 mg/L) and were enrolled in the study.

2 patients withdrew consent prior to beginning the study. 1 patient underwent a change in heart failure medication prior to beginning the study and was therefore withdrawn from the study. The 8 remaining patients began the study interventions.

Participant milestones

Participant milestones
Measure	Anakinra Anakinra 100 mg subcutaneous daily injection
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Anakinra Anakinra 100 mg subcutaneous daily injection
Overall Study Adverse Event	1

Baseline Characteristics

Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anakinra n=8 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight. The outcome measure time frame was 14 days. This means that change in peak VO2 was calculated as the difference between peak VO2 at baseline and 14 days. To calculate this change, we used the mathematical process of subtraction (change in peak VO2 = Peak VO2 \[day 14\] - Peak VO2 \[baseline\])

Outcome measures

Outcome measures
Measure	Anakinra n=7 Participants Anakinra 100 mg subcutaneous daily injection
Median Interval Change From Baseline in Peak VO2	3.90 mL/kg/min Interval 2.3 to 4.95

PRIMARY outcome

Timeframe: 14 days

The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless. Change in VE/VCO2 slope was calculated as the change in VE/VCO2 slope between baseline and 14 days. We therefore calculated the difference between VE/VCO2 slope measurements that occurred at baseline and at 14 days (change in VE/VCO2 slope = VE/VCO2 slope \[day 14\] - VE/VCO2 slope \[baseline\])

Outcome measures

Outcome measures
Measure	Anakinra n=7 Participants Anakinra 100 mg subcutaneous daily injection
Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)	-2.10 (unitless) Interval -4.1 to -0.55

SECONDARY outcome

Timeframe: 14 days

The Duke Activity Status Index (DASI) is a scale that quantifies patients' ability to perform various tasks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores reflect improved activity or improved heart failure symptoms. Lower scores reflect worsened ability or worsened heart failure symptoms.

Outcome measures

Outcome measures
Measure	Anakinra n=7 Participants Anakinra 100 mg subcutaneous daily injection
Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)	6 units on a scale Interval 0.0 to 20.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days

Outcome measures

Outcome data not reported

Adverse Events

Anakinra

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anakinra n=8 participants at risk
General disorders Flu-like symptoms	12.5% 1/8 • Number of events 1

Additional Information

Benjamin Van Tassell

Virginia Commonwealth University

Phone: 8049820997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place