Effects of levothyroxine in subclinical hypothyroidism and heart failure with reduced ejection fraction : An open-label randomized trial
Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:5 |
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| Enthalten in: |
Cell reports. Medicine - 5(2024), 4 vom: 16. Apr., Seite 101473 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wang, Wenyao [VerfasserIn] |
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| Links: |
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| Themen: |
6MWT |
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| Anmerkungen: |
Date Completed 19.04.2024 Date Revised 26.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT03096613 Citation Status MEDLINE |
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| doi: |
10.1016/j.xcrm.2024.101473 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM370271769 |
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| 520 | |a Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a 6MWT | |
| 650 | 4 | |a NYHA | |
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| 700 | 1 | |a Zhang, Xuan |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Meng, Xiangbin |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jingjia |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Kuo |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Jing |e verfasserin |4 aut | |
| 700 | 1 | |a Qi, Jiating |e verfasserin |4 aut | |
| 700 | 1 | |a Shao, Chunli |e verfasserin |4 aut | |
| 700 | 1 | |a Tang, Yi-Da |e verfasserin |4 aut | |
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