Interleukin-1 Blockade in Recently Decompensated Heart Failure

NCT01936909 ↗

Phase 2/3 Completed 60 enrolled Virginia Commonwealth University National Heart, Lung, and Blood Institute (NHLBI) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.

Timeline

Start: 2014-02
Primary completion: 2016-09-23
Completion: 2016-09-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Anakinra (Short) vs Anakinra (Long) vs Placebo; p >0.20; ANOVA NCT01936909 ↗

paper Treatment with anakinra did not affect peak Vo2 or VE/Vco2 slope at 2 weeks. PMID 29141858 ↗

Publications

Van Tassell BW, Canada J, Carbone S, Trankle C, Buckley L, Oddi Erdle C, Abouzaki NA, Dixon D, Kadariya D, Christopher S, Schatz A, Regan J, Viscusi M, Del Buono M, Melchior R, Mankad P, Lu J, Sculthorpe R, Biondi-Zoccai G, Lesnefsky E, Arena R, Abbate A. Interleukin-1 Blockade in Recently Decompensated Systolic Heart Failure: Results From REDHART (Recently Decompensated Heart Failure Anakinra Response Trial). Circ Heart Fail. 2017 Nov;10(11):e004373. doi: 10.1161/CIRCHEARTFAILURE.117.004373.

Drugs

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