PMID- 38537636 OWN - NLM STAT- MEDLINE DCOM- 20240419 LR - 20240502 IS - 2666-3791 (Electronic) IS - 2666-3791 (Linking) VI - 5 IP - 4 DP - 2024 Apr 16 TI - Effects of levothyroxine in subclinical hypothyroidism and heart failure with reduced ejection fraction: An open-label randomized trial. PG - 101473 LID - S2666-3791(24)00119-8 [pii] LID - 10.1016/j.xcrm.2024.101473 [doi] LID - 101473 AB - We report a randomized, multicenter, open-label trial (ClinicalTrials.gov: NCT03096613) to investigate the clinical benefits of levothyroxine (L-T4) administration in subclinical hypothyroidism (SCH) patients with heart failure with reduced ejection fraction (HFrEF). Overall, 117 patients were enrolled and received L-T4 plus standard HFrEF treatment (experimental group, N = 57) or standard HFrEF therapy alone (control group, N = 60). The change of 6-min walk test distance in the experimental group was significantly higher than that in the control group at 24 weeks (70.08 +/- 85.76 m vs. 27.73 +/- 82.00 m, mean difference [95% confidence interval (CI)] 46.90 [12.90, 80.90], p < 0.001). Improvements in New York Heart Association (NYHA) classification (p = 0.033) and thyroid function were significant. Adverse event incidence was similar between groups (risk ratio [95% CI]: 0.942 1.053 (0.424, 2.616); p = 0.628). L-T4 addition to HFrEF treatment improved activity tolerance, NYHA class, and thyroid function within 6 months, suggesting its potential for combined therapy in HFrEF patients with SCH. Future double-blind, placebo-controlled trials should be performed to confirm these results. CI - Copyright (c) 2024 The Authors. Published by Elsevier Inc. All rights reserved. FAU - Wang, Wenyao AU - Wang W AD - Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing, China. FAU - Zhang, Xuan AU - Zhang X AD - Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Gao, Jun AU - Gao J AD - Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing, China. FAU - Meng, Xiangbin AU - Meng X AD - Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing, China. FAU - Wang, Jingjia AU - Wang J AD - Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing, China. FAU - Zhang, Kuo AU - Zhang K AD - Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Chen, Jing AU - Chen J AD - Department of Cardiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Qi, Jiating AU - Qi J AD - Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing, China. FAU - Shao, Chunli AU - Shao C AD - Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing, China. FAU - Tang, Yi-Da AU - Tang YD AD - Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing, China. Electronic address: tangyida@bjmu.edu.cn. LA - eng SI - ClinicalTrials.gov/NCT03096613 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20240326 PL - United States TA - Cell Rep Med JT - Cell reports. Medicine JID - 101766894 RN - Q51BO43MG4 (Thyroxine) SB - IM MH - Humans MH - Double-Blind Method MH - *Heart Failure MH - *Hypothyroidism/drug therapy MH - Stroke Volume MH - Thyroxine/therapeutic use PMC - PMC11031377 OTO - NOTNLM OT - 6MWT OT - NYHA OT - chronic heart failure OT - levothyroxine OT - subclinical hypothyroidism COIS- Declaration of interests The authors declare no competing interests. EDAT- 2024/03/28 00:45 MHDA- 2024/04/19 06:43 PMCR- 2024/03/26 CRDT- 2024/03/27 19:41 PHST- 2023/09/06 00:00 [received] PHST- 2024/01/05 00:00 [revised] PHST- 2024/02/21 00:00 [accepted] PHST- 2024/04/19 06:43 [medline] PHST- 2024/03/28 00:45 [pubmed] PHST- 2024/03/27 19:41 [entrez] PHST- 2024/03/26 00:00 [pmc-release] AID - S2666-3791(24)00119-8 [pii] AID - 101473 [pii] AID - 10.1016/j.xcrm.2024.101473 [doi] PST - ppublish SO - Cell Rep Med. 2024 Apr 16;5(4):101473. doi: 10.1016/j.xcrm.2024.101473. Epub 2024 Mar 26.