PMID- 35445052 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231102 IS - 2296-858X (Print) IS - 2296-858X (Electronic) IS - 2296-858X (Linking) VI - 9 DP - 2022 TI - Cardiovascular Protective Effects of Oral Hypoxia Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat in the Treatment of Type 4 Cardiorenal-Anemia Syndrome: Protocol of a Randomized Controlled Trial. PG - 783387 LID - 10.3389/fmed.2022.783387 [doi] LID - 783387 AB - BACKGROUND: Patients with chronic kidney disease (CKD) are at high risk of developing heart failure and anemia, which is defined as type 4 cardiorenal-anemia syndrome (CRAS). CRAS aggravates the deterioration of both kidney and heart function, ultimately resulting in a high mortality. This study aims to examine the efficacy and safety of roxadustat in the treatment of type 4 CRAS. METHODS AND DESIGN: This study is designed as a randomized, open-label, controlled trial. A total of 68 patients diagnosed with type 4 CRAS will be randomly divided into roxadustat group and erythropoietin with a 1:1 ratio. Participants in the roxadustat group will receive roxadustat with an initial dose of 70 or 100 mg three times a week, and participants in the erythropoietin group will receive subcutaneous injection of erythropoietin for 24 weeks, to maintain a hemoglobin ranging from 100 to 120 g per liter. The primary outcome is the change in heart function, including brain natriuretic peptide (BNP), 6-min walk test (6-WT), and left ventricular ejection fraction (LVEF). Secondary outcomes to be assessed include death, cardiovascular events, hospitalization regarding heart failure, Minnesota Heart Failure Quality of life scale (MLHFQ) score, New York Heart Association (NYHA) cardiac function grade, echocardiographic parameters including left ventricular diastolic diameter and volume (LVDD and LVDV) and ventricular mass (LVM), anemia related parameters, inflammatory parameters, and safety assessments. CONCLUSION: The findings of this study will provide potential evidence for roxadustat in CRAS management. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ID: ChiCTR2100050031. Registered on 16 August 2021. CI - Copyright (c) 2022 Wen, Xu, Tian, Jiang, Jiang and Li. FAU - Wen, Yumin AU - Wen Y AD - Department of Nephrology, Beijing Hepingli Hospital, Beijing, China. FAU - Xu, Yang AU - Xu Y AD - Department of Nephrology, Beijing Hepingli Hospital, Beijing, China. FAU - Tian, Hui AU - Tian H AD - Department of Nephrology, Beijing Hepingli Hospital, Beijing, China. FAU - Jiang, Sizhu AU - Jiang S AD - Department of Nephrology, Beijing Hepingli Hospital, Beijing, China. FAU - Jiang, Guofang AU - Jiang G AD - Department of Nephrology, Beijing Hepingli Hospital, Beijing, China. FAU - Li, Puqing AU - Li P AD - Department of Nephrology, Beijing Hepingli Hospital, Beijing, China. LA - eng PT - Journal Article DEP - 20220404 PL - Switzerland TA - Front Med (Lausanne) JT - Frontiers in medicine JID - 101648047 PMC - PMC9013811 OTO - NOTNLM OT - anemia OT - cardiorenal-anemia syndrome OT - chronic kidney disease OT - heart failure OT - roxadustat COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/04/22 06:00 MHDA- 2022/04/22 06:01 PMCR- 2022/04/04 CRDT- 2022/04/21 05:45 PHST- 2021/09/26 00:00 [received] PHST- 2022/03/07 00:00 [accepted] PHST- 2022/04/21 05:45 [entrez] PHST- 2022/04/22 06:00 [pubmed] PHST- 2022/04/22 06:01 [medline] PHST- 2022/04/04 00:00 [pmc-release] AID - 10.3389/fmed.2022.783387 [doi] PST - epublish SO - Front Med (Lausanne). 2022 Apr 4;9:783387. doi: 10.3389/fmed.2022.783387. eCollection 2022.