Heart Failure Clinical Trial
Official title:
Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure: Study Protocol for a Randomized Controlled Trial
This trial will assess the efficacy and safety of QSG in CHF.
Background: Chronic heart failure(CHF), the final stage of various cardiovascular diseases,
is a major public health problem associated with significant hospitalization rates,
mortality, and huge health care costs, despite advances in the treatment and management of
heart failure and heart failure related risk factors. Qishen granules(QSG), a Chinese herbal
formula, is widely used by traditional chinese medicine(TCM) practitioners to treat CHF.
Several animal experimental studies have showed that QSG can significantly relieve the heart
failure symptoms of CHF rat models. However, there is yet no standard clinical trial to
assess that. Thus, the investigators are conducting this study to evaluate the efficacy and
safety of QSG in a large, varied population.
Methods/Design: This study is designed as a randomized, multi-center, placebo-controlled,
double-blind , parallel-group clinical trial. An established total of 200 patients with CHF
will be recruited and randomly allocated to either the QSG treatment group or the placebo
group (a 1:1 ratio). The patients will receive QSG or placebo granules twice daily for 12
weeks. The primary endpoint is the reduction or percent change in the plasma N-terminal
pro-B-type natriuretic peptide(NT-proBNP) level during 12 weeks of treatment. The secondary
endpoints consist of composite cardiac events (CCEs), New York Heart Association (NYHA)
functional classification, 6-minute walking distance (6MWD), Left ventricular ejection
fraction, patient quality of life and TCM syndrome integral scale.
Discussion: This trial will assess the efficacy and safety of QSG in CHF.
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