ArticleFrontiers in cardiovascular medicine2026
Efficacy and safety of Shengxian Yixin Granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial.
Article in Frontiers in cardiovascular medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Heart failure with preserved ejection fraction (HFpEF) is a highly complex clinical syndrome associated with significant morbidity and mortality. Its underlying mechanisms are poorly understood, treatment options are limited, the disease burden on patients is substantial, and clinical outcomes are poor. Previous clinical studies have preliminarily suggested that Shengxian Yixin Granule (SXYX) is an effective herbal formula for the treatment of HFpEF, but it lacks high-quality clinical evidence. This study therefore plans to conduct a randomized controlled trial (RCT) to evaluate the efficacy and safety of SXYX in treating HFpEF, aiming to provide a new therapeutic strategy for this condition. Methods: This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. It will be conducted at four Chinese medicine hospitals in China. A total of 148 eligible patients with HFpEF will be enrolled and randomly assigned in a 1:1 ratio to the SXYX group or the placebo group. The SXYX group will receive Shengxian Yixin Granule, while the placebo group will receive a matching placebo. Both groups will receive standard Western medical therapy as background treatment. The treatment duration for all groups is 24 weeks. The primary outcome is the change in peak VO Discussion: This study will evaluate the efficacy and safety of SXYX in treating HFpEF. The findings will provide a scientific basis for the clinical application of SXYX. Clinical Trial Registration: https://itmctr.ccebtcm.org.cn, identifier ITMCTR2026000833.
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