drugset / Trial / NCT03797001
Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2
RandomizedParallel-groupQuadruple-blindTreatment
Summary
REDHART2 is a randomized, double-blinded, placebo-controlled trial to determine the effects of Anakinra on peak aerobic exercise capacity measured with a cardiopulmonary test after 24 weeks in patients with recently decompensated systolic heart failure and increased systemic inflammation.
Timeline
- Start
- 2019-01-04
- Primary completion
- 2024-07-22
- Completion
- 2024-07-22
Publications
- Van Tassell BW, Golino M, Canada JM, Markley R, Billingsley H, Del Buono MG, Talasaz A, Thomas G, Chiabrando JG, Wohlford G, Dickson V, Kadariya D, Damonte JI, Ho AJ, Sedhai YR, Kontos E, Vecchie A, West JD, Corna G, Medina de Chazal H, Pinel S, Bressi E, Barron A, Dell M, Mbualungu J, Moroni F, Turlington J, Federmann E, Trankle CR, Carbone S, Arena R, Abbate A. Resolution of Systemic Inflammation in Patients With Recently Decompensated Heart Failure With Reduced Ejection Fraction With and Without Interleukin-1 Blockade by Anakinra. Circ Heart Fail. 2026 Mar;19(3):e013546. doi: 10.1161/CIRCHEARTFAILURE.125.013546. Epub 2025 Dec 23.
- Van Tassell B, Mihalick V, Thomas G, Marawan A, Talasaz AH, Lu J, Kang L, Ladd A, Damonte JI, Dixon DL, Markley R, Turlington J, Federmann E, Del Buono MG, Biondi-Zoccai G, Canada JM, Arena R, Abbate A. Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study. J Transl Med. 2022 Jun 15;20(1):270. doi: 10.1186/s12967-022-03466-9.
- Sedhai YR, Patel NK, Mihalick V, Talasaz A, Thomas G, Denlinger BL, Damonte JI, Del Buono MG, Federmann E, Hardin M, Ibe I, Harmon M, Van Tassell B, Abbate A. Heart failure clinical trial enrollment at a rural satellite hospital. Contemp Clin Trials. 2022 Apr;115:106731. doi: 10.1016/j.cct.2022.106731. Epub 2022 Mar 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |