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Efficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial.

  • 2025-08-06
  • BMC complementary medicine and therapies 25(1)
    • Huiqi Chen
    • Zhibo Li
    • Meiyi Su
    • Guanghui Song
    • Sien Guo
    • Wenwei Feng
    • Wensheng Chen
    • Chun Li
    • Lei Wang
    • Wei Wang

Study Design

Type
Randomized Controlled Trial (RCT)
Population
Eighty eligible participants with HFpEF
Methods
multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial; 1:1 ratio; QSG treatment or placebo for 12 weeks, with all participants maintaining guideline-directed HFpEF therapy
Blinding
Double-blind
Duration
12 weeks

Background

Heart failure with preserved ejection fraction (HFpEF) is a multifaceted clinical condition that comprises nearly 50% of all heart failure cases, making it a significant clinical challenge. Qishen granule (QSG) is a promising traditional Chinese medicine (TCM) treatment that shows cardioprotective potential against chronic heart failure, as evidenced in previous studies. This trial intends to perform a prospective clinical study to observe the efficacy and safety of QSG on HFpEF.

Methods

This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. Eighty eligible participants with HFpEF will be enrolled and randomly assigned in a 1:1 ratio and receive either the QSG treatment or placebo for 12 weeks, with all participants maintaining guideline-directed HFpEF therapy throughout the study period. The primary outcomes are changes in peak VO2 measured by cardiopulmonary exercise testing (CPET), and plasma NT-proBNP level from baseline to endpoint. Secondary outcomes include changes in echocardiography parameters, serum soluble human growth stimulation expressed gene 2 (ST2) protein levels, TCM syndrome integral scale score, quality of life and other indicators in CPET. Safety indicators like blood tests of liver and renal function and adverse events are used to assess the safety of QSG.

Discussion

This study's result may establish clinical evidence supporting QSG's therapeutic benefits and safety in HFpEF management.

Trial registration

https://clinicaltrials.gov/ .

Registration number

NCT06377761. Registered on 2 June 2022.

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