Clinical efficacy of modified Yanghe decoction in the treatment of elderly HFpEF and its impact on extracellular matrix regulatory biomarkers

Background: Heart failure with preserved ejection fraction (HFpEF) has the highest incidence of senile heart failure (HF), and no effective treatments are currently available. Traditional Chinese medicine is an important complementary alternative therapy for HF prevention and treatment, but there is a lack of systematic and standardized clinical studies on HFpEF. The aim of this study was to evaluate the efficacy, long-term prognosis and safety of the modified Yanghe decoction in elderly patients with HFpEF and to determine whether it plays an anti-HF role by regulating extracellular matrix homeostasis. Methods: The proposed study was a randomized, double-blind, placebo-controlled prospective trial that included 138 patients with stable HFpEF. Safety assessments will be performed before enrollment, patients will be randomly assigned to the treatment or control group, and the corresponding assessments will be completed after enrollment. The intervention group will receive modified Yanghe decoction granules under supervision for 4 weeks, and the control group will receive placebo granules under supervision for 4 weeks. After 4 weeks, the safety and efficacy indices of the patients will be evaluated again. Patients will be followed up by telephone or via WeChat for 6 months to evaluate the long-term prognosis and safety of modified Yanghe decoction granules in elderly patients with HFpEF. Discussion: The objective of this study is to evaluate the effect of modified Yanghe decoction granules on the efficacy, long-term prognosis, and safety of treatment in elderly patients with HFpEF, and to elucidate the possible regulatory mechanism of modified Yanghe decoction granules on myocardial extracellular matrix homeostasis, in order to provide a scientific basis for the use of modified Yanghe decoction granules to intervene in myocardial fibrosis and remodeling in elderly patients with HFpEF.