Trial Outcomes & Findings for Interleukin-1 Receptor Antagonist for the Treatment of Heart Failure in Patients With Left Ventricular Assist Devices (NCT NCT02547766)

Results Overview

The primary endpoint was a reduction in inflammatory markers, specifically C-reactive protein (CRP).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6 months post treatment

Results posted on

2020-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	Anakinra Arm All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect. Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Anakinra Arm All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect. Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Interleukin-1 Receptor Antagonist for the Treatment of Heart Failure in Patients With Left Ventricular Assist Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anakinra Arm n=10 Participants All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect. Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days.
Age, Continuous	50 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post treatment

Population: Patients

The primary endpoint was a reduction in inflammatory markers, specifically C-reactive protein (CRP).

Outcome measures

Outcome measures
Measure	Anakinra Arm n=10 Participants All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect. Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days.
Biologic Efficacy: Inflammation Marker - C-Reactive Protein At 6 months	0.6 mg/dL Interval 0.5 to 1.7
Biologic Efficacy: Inflammation Marker - C-Reactive Protein Prior to Anakinra	2.5 mg/dL Interval 1.1 to 3.0
Biologic Efficacy: Inflammation Marker - C-Reactive Protein After Anakinra	0.6 mg/dL Interval 0.4 to 1.8

SECONDARY outcome

Timeframe: 6 months post treatment

Population: Patients

Secondary endpoints included the measure of additional inflammatory markers, including neutrophil count.

Outcome measures

Outcome measures
Measure	Anakinra Arm n=10 Participants All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect. Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days.
Biologic Efficacy: Inflammation Marker - Neutrophil Count Prior to Anakinra	6.4 10^3 cells/µL Interval 5.7 to 6.7
Biologic Efficacy: Inflammation Marker - Neutrophil Count After Anakinra	5.0 10^3 cells/µL Interval 2.8 to 5.4
Biologic Efficacy: Inflammation Marker - Neutrophil Count At 6 months	4.4 10^3 cells/µL Interval 3.6 to 5.3

SECONDARY outcome

Timeframe: 6 months post treatment

Population: Patients

Clinical efficacy was a secondary endpoint that was measured using ejection fraction (EF)

Outcome measures

Outcome measures
Measure	Anakinra Arm n=10 Participants All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect. Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days.
Clinical Efficacy: Ejection Fraction Prior to Anakinra	15 percentage of blood leaving heart Interval 15.0 to 30.0
Clinical Efficacy: Ejection Fraction At 6 months	25 percentage of blood leaving heart Interval 15.0 to 50.0
Clinical Efficacy: Ejection Fraction After Anakinra	15 percentage of blood leaving heart Interval 15.0 to 47.0

SECONDARY outcome

Timeframe: 6 months post treatment

Population: Patients

Secondary endpoints included the measure of additional inflammatory markers, including TNFalpha.

Outcome measures

Outcome measures
Measure	Anakinra Arm n=10 Participants All patients in this arm receive Anakinra in a pre-post design. That is, outcome markers are measured, the intervention (Anakinra) is applied, and the outcome markers are measured again at various intervals to determine effect. Anakinra: Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days.
Biologic Efficacy: Inflammation Marker - TNFalpha Prior to Anakinra	4 pg/mL Interval 4.0 to 6.0
Biologic Efficacy: Inflammation Marker - TNFalpha After Anakinra	9 pg/mL Interval 4.0 to 30.0
Biologic Efficacy: Inflammation Marker - TNFalpha At 6 months	4 pg/mL Interval 4.0 to 33.0

Adverse Events

Anakinra Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Director of Clinical Trials

University of Utah

Phone: 801-581-5318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place