Trial Outcomes & Findings for Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction (NCT NCT01542502)

Results Overview

The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

14 days

Results posted on

2017-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Anakinra (First) Then Placebo (Second) Treatment with daily subcutaneous injections of Anakinra 100 mg for 14 days, followed by daily subcutaneous injections of Placebo for 14 days Anakinra: Anakinra 100 mg daily subcutaneous injection Placebo: Placebo daily subcutaneous injection	Placebo (First) Then Anakinra (Second) Treatment with daily subcutaneous injections of Placebo for 14 days, followed by daily subcutaneous injections of Anakinra for 14 days Placebo: Placebo daily subcutaneous injection Anakinra: Anakinra 100 mg daily subcutaneous injection
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 Participants Baseline measures for all study participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants
Gender Female	11 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).

Outcome measures

Outcome measures
Measure	Anakinra n=12 Participants Treatment with daily subcutaneous injections of Anakinra 100 mg Anakinra: Anakinra 100 mg daily subcutaneous injection	Placebo n=12 Participants Treatment with daily subcutaneous injection of placebo Placebo: Placebo daily subcutaneous injection
Peak Oxygen Consumption (Peak VO2)	1.1 mlkg^-1min^-1 Interval 0.6 to 2.3	-0.1 mlkg^-1min^-1 Interval -0.5 to 1.0

SECONDARY outcome

Timeframe: 14 days

Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment

Outcome measures

Outcome measures
Measure	Anakinra n=12 Participants Treatment with daily subcutaneous injections of Anakinra 100 mg Anakinra: Anakinra 100 mg daily subcutaneous injection	Placebo n=12 Participants Treatment with daily subcutaneous injection of placebo Placebo: Placebo daily subcutaneous injection
Exercise Time	0.05 minutes Interval -0.05 to 0.85	0.4 minutes Interval 0.025 to 0.925

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Correlation between interval change in peak VO2 and high sensitivity C-reactive protein

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Interval change from baseline in Heart Failure (HF) symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Additional endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Interval change from baseline in high-sensitivity C-reactive protein upon completion of 2 weeks treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days

Interval change from baseline in ventilatory efficiency (VE/VCO2 slope) upon completion of 2 weeks treatment.

Outcome measures

Outcome data not reported

Adverse Events

Anakinra

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anakinra n=12 participants at risk Treatment with daily subcutaneous injections of Anakinra 100 mg Anakinra: Anakinra 100 mg daily subcutaneous injection	Placebo n=12 participants at risk Treatment with daily subcutaneous injection of placebo Placebo: Placebo daily subcutaneous injection
Skin and subcutaneous tissue disorders Injection site reactions	25.0% 3/12 • 28 days	0.00% 0/12 • 28 days

Additional Information

Antonio Abbate

Virginia Commonwealth University

Phone: 804-828-0513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place