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Rivaroxaban Once-Daily vs. Dose-Adjusted Vitamin K Antagonist on Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF): Rationale and Design of an Investigator-Initiated Multicenter Randomized Prospective Open-Labeled Pilot Clinical Study

  • 주제(키워드) rivaroxaban , acute decompensated heart failure , atrial fibrillation , vitamin K antagonist (VKA) , biomarker
  • 주제(기타) Cardiac & Cardiovascular Systems
  • 설명문(일반) [Cho, Iksung; Oh, Jaewon; Kang, Seok-Min] Yonsei Univ, Cardiovasc Res Inst, Severance Cardiovascular Hosp, Cardiol Div,Coll Med, Seoul, South Korea; [Kim, In-Cheol] Keimyung Univ, Div Cardiol, Dongsan Med Ctr, Daegu, South Korea; [Chung, Hyemoon] Kyung Hee Univ, Div Cardiol, Dept Internal Med, Seoul, South Korea; [Lee, Jung-Hee] Yeungnam Univ Med Ctr, Div Cardiol, Dept Internal Med, Daegu, South Korea; [Kim, Hyue Mee] Chung Ang Univ, Div Cardiol, Dept Internal Med, Seoul, South Korea; [Byun, Young Sup] Inje Univ, Sanggye Paik Hosp, Div Cardiol, Seoul, South Korea; [Yoo, Byung-Su] Yonsei Univ, Dept Internal Med, Coll Med, Wonju, South Korea; [Choi, Eui-Young] Yonsei Univ, Gangnam Severance Hosp, Div Cardiol, Heart Ctr,Coll Med, Seoul, South Korea; [Chung, Wook-Jin] Gachon Univ, Gil Med Ctr, Dept Cardiovasc Med, Incheon, South Korea; [Pyun, Wook Bum] Ewha Womans Univ, Div Cardiol, Dept Internal Med, Seoul, South Korea
  • 등재 SCIE, SCOPUS
  • 발행기관 FRONTIERS MEDIA SA
  • 발행년도 2022
  • 총서유형 Journal
  • URI http://www.dcollection.net/handler/ewha/000000190817
  • 본문언어 영어
  • Published As https://doi.org/10.3389/fcvm.2021.765081
  • PubMed https://pubmed.ncbi.nlm.nih.gov/35096995

초록/요약

Background: Clinical trials of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with chronic heart failure and atrial fibrillation (AF) have demonstrated reduced risks of stroke and bleeding compared with vitamin K antagonists (VKAs). Here, we aim to assess the clinical efficacy and safety of rivaroxaban, a NOAC, compared with warfarin, a VKA, and the effects of rivaroxaban on cardiovascular biomarkers in patients with acute decompensated heart failure (ADHF) with reduced ejection fraction (& LE;40%) and AF.Methods: Rivaroxaban Once-daily vs. dose-adjusted vitamin K antagonist on biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF) is a randomized, open-labeled, controlled, prospective, multicenter pilot study designed to assess cardiovascular biomarkers and the safety of rivaroxaban (20 or 15 mg in patients with creatinine clearance 30-49 mL/min per day) compared with VKA (target international normalized range: 2-3) in 150 patients hospitalized with ADHF and AF. The primary endpoint is the change in circulating high-sensitivity cardiac troponin (hsTn) during hospitalization. The secondary endpoints are bleeding, hospital stay duration, in-hospital mortality, and changes in cardiovascular, renal, and thrombosis biomarkers. Patients will be followed for 180 days.Conclusion: We hypothesize that rivaroxaban will reduce myocardial injury and hemodynamic stress, as reflected by the biomarker status, within 72 h in patients with ADHF and AF, compared with VKA. We hope to facilitate future biomarker-based, large-scale outcome trials using NOACs in patients with ADHF and AF, based on the results of this multicenter, randomized, controlled study.

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