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

Summary

This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.

Timeline

Start

2012-02

Primary completion

2013-06

Completion

2013-06

Outcome

Met primary endpoint

registry MEDIAN Anakinra: 1.1 (0.6 to 2.3) ml*kg^-1*min^-1 NCT01542502 ↗

registry analysis (superiority or other test); Anakinra vs Placebo; p = 0.009; ANOVA NCT01542502 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anakinra	Protein / enzyme biologic	100 mg	Subcutaneous

Indications