Rationale and Design of the ADIDAS Study: Association Between Dapagliflozin-Induced Improvement and Anemia in Heart Failure Patients

Jianping Zeng, Yunlong Zhu, Wenjiao Zhao, Mingxing Wu, Haobo Huang, He Huang, ChunFeng Wu, XiaoLin Zhou, ShengHua Zhou, ChengMing Wang, Kai Yin, FangHua Xu, ZhiQiang Cai, Xinyang Li, Huiheng Cheng, Youwen Xie, Zhuqing Tan, Xiaoyong Hu, Dexiang Liao, Yingchun Wang, Jianping Zeng, Yunlong Zhu, Wenjiao Zhao, Mingxing Wu, Haobo Huang, He Huang, ChunFeng Wu, XiaoLin Zhou, ShengHua Zhou, ChengMing Wang, Kai Yin, FangHua Xu, ZhiQiang Cai, Xinyang Li, Huiheng Cheng, Youwen Xie, Zhuqing Tan, Xiaoyong Hu, Dexiang Liao, Yingchun Wang

Abstract

Background: Heart failure (HF) is one of the most serious health concerns worldwide. Anemia is a highly prevalent comorbidity and outcome predictor in HF patients. Sodium glucose co-transport 2 (SGLT2) inhibitors have been demonstrated to reduce the risk of cardiovascular death and HF hospitalization in HF patients.

Purpose: This investigator-initiated, interventional, prospective, double-blind, multicenter study is designed to investigate whether anemia correction is one of the prerequisites and determinants related to the beneficial effects of dapagliflozin in HF patients.

Methods and results: Up to 2030 HF participants receiving standard care will be randomly assigned to either oral dapagliflozin 10 mg once daily or placebo 10 mg once daily for 12 months. The primary outcome is the composite incidence of hospital admission for HF and all-cause death. Secondary outcomes include change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and change in 6-min walk distance and hemoglobin level. Patients will be followed for 12 months after randomization.

Conclusions: The ADIDAS trial offers an opportunity to assess the hemoglobin change and association between hemoglobin change and readmissions due to heart failure and all-cause death in patients with heart failure treated with dapagliflozin or placebo. This study could highlight if dynamic hemoglobin change is related to the outcome for HF patients.

Trial registration: ClinicalTrials.gov ; NCT04707261. Registration date, 2020/12/01, "retrospectively registered".

Keywords: Anemia; Dapagliflozin; Heart failure; Outcome.

Conflict of interest statement

The authors declare no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
ADIDAS trial design diagram. R, randomization; Qd, once daily; p.o., orally

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