drugset / Trial / NCT03096613
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Chronic Heart Failure (ThyroHeart-CHF)
Phase 4
Unknown
124 enrolled
Chinese Academy of Medical Sciences, Fuwai Hospital
Henan Provincial People's Hospital · collabThe First Hospital of Hebei Medical University · collabThe Luhe Teaching Hospital of the Capital Medical University · collabTianjin Medical University Second Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Based on accumulating evidence showing that hypothyroid status is associated with poor prognosis among heart failure (HF) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with HF and subclinical hypothyroidism. The study is a prospective, randomized, parallel-group trial to assess the efficacy and safety of levothyroxine replacement on evidence-based HF standard therapy in stable chronic heart failure patients with subclinical hypothyroidism.
Timeline
- Start
- 2017-04-18
- Primary completion
- 2019-02
- Completion
- 2019-02
Publications
- Wang W, Zhang X, Gao J, Meng X, Wang J, Zhang K, Chen J, Qi J, Shao C, Tang YD. Effects of levothyroxine in subclinical hypothyroidism and heart failure with reduced ejection fraction: An open-label randomized trial. Cell Rep Med. 2024 Apr 16;5(4):101473. doi: 10.1016/j.xcrm.2024.101473. Epub 2024 Mar 26.
- Zhang X, Wang WY, Zhang K, Tian J, Zheng JL, Chen J, An SM, Wang SY, Liu YP, Zhao Y, Wang JJ, Yang M, Tang YD. Efficacy and safety of levothyroxine (L-T4) replacement on the exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism: Study protocol for a multi-center, open label, randomized, parallel group trial (ThyroHeart-CHF). Trials. 2019 Feb 19;20(1):143. doi: 10.1186/s13063-019-3219-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levothyroxine | Other / unclassified | — | — |