drugset / Trial / NCT02173548
Interleukin-1 Blockade in HF With Preserved EF
Phase 2
Completed
31 enrolled
Virginia Commonwealth University
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
* Heart Failure with Preserved Ejection Fraction (HFpEF) is a common form of heart failure * Standard treatment for heart failure, show less than ideal results in HFpEF * Evidence of systemic inflammation is common in all forms of heart failure, including HFpEF * The main hypothesis of this study is that systemic inflammation contributes to heart failure symptoms and exercise limitations in patients with HFpEF * The main objective is to treat patients with HFpEF and evidence of systemic inflammation with an anti-inflammatory drug targeting Interleukin-1 (or placebo) to determine effects on cardiovascular function
Timeline
- Start
- 2014-09
- Primary completion
- 2017-04-11
- Completion
- 2017-06-01
Publications
- Van Tassell BW, Trankle CR, Canada JM, Carbone S, Buckley L, Kadariya D, Del Buono MG, Billingsley H, Wohlford G, Viscusi M, Oddi-Erdle C, Abouzaki NA, Dixon D, Biondi-Zoccai G, Arena R, Abbate A. IL-1 Blockade in Patients With Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Aug;11(8):e005036. doi: 10.1161/CIRCHEARTFAILURE.118.005036.
- Van Tassell BW, Buckley LF, Carbone S, Trankle CR, Canada JM, Dixon DL, Abouzaki N, Oddi-Erdle C, Biondi-Zoccai G, Arena R, Abbate A. Interleukin-1 blockade in heart failure with preserved ejection fraction: rationale and design of the Diastolic Heart Failure Anakinra Response Trial 2 (D-HART2). Clin Cardiol. 2017 Sep;40(9):626-632. doi: 10.1002/clc.22719. Epub 2017 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |