This study was designed as a randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the efficacy and safety of Zhigancao Tang granule in patients with HFpEF of Qi-Yin dificiency.
Heart failure with preserved ejection fraction (HFPEF) is a clinical syndrome characterized by diastolic dysfunction.The incidence of HFpEF is increasing in recent years. Standard treatment of heart failure does not improve the prognosis of HFPEF patients. Zhigancao Tang was used to improve the symptoms of chronic heart failure in China.This randomized,double-blinded and placebo-controlled trial will objectively and standardly evaluate the effectiveness and safety of Zhigancao Tang granule.After 12 weeks of treatment, 122 HFpEF patients with deficiency of Qi and Yin were observed and evaluated in terms of heart function, clinical symptoms,exercise tolerance and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
122
Zhigancao Tang: Dissolve Zhigancao Tang granule in 200ml hot water, twice a day,12 weeks, oral. Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.
Zhigancao Tang placebo: Dissolve Zhigancao Tang placebo granule in 200ml hot water, twice a day,12 weeks, oral. Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.
Longhua Hospital
Shanghai, Shanghai Municipality, China
Cardiac Functional Grading
Significant effect: cardiac function recovered to level 1 or increased by level 2; Effective: cardiac function increased by level 1 but failed to reach level 2; Ineffective: cardiac function did not change; Worsening: cardiac function decreased by level 1 or above.
Time frame: 12 weeks
Ultrasonic cardiogram
Echocardiographic measurement of Left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDd), left ventricular end systolic diameter (LVESD), ratio of left ventricular early diastolic fast filling peak to late diastolic filling peak (E / a), ratio of early diastolic velocity of mitral valve to early diastolic annular velocity (E / E ').
Time frame: 12 weeks
6-min walking test (6mwt)
6 minute walking test (6mwt) is a measure of the distance the patient can reach as far as possible by walking on a hard ground without obstacles within six minutes at the fastest possible speed. It provides a comprehensive assessment of exercise capacity.
Time frame: 12 weeks
Minnesota Heart Failure Quality of Life Scale
Minnesota Heart Failure Quality of Life Scale was used to assess the impact of heart failure on life in the last four weeks. A total of 21 questions related to physical and emotional change. Higher scores mean a worse outcome.
Time frame: 12 weeks
N-terminal pro-B-type natriuretic peptide（NT-proBNP）
NT-proBNP is a reliable and sensitive indicator of heart failure. Its elevation is positively correlated with severity of heart failure.
Time frame: 12 weeks
TCM syndrome score
TCM syndrome score is used to assess changes in Qi-Yin Dificiency related symptoms during treatment. The higher the scores, the more heart failure symptoms. Higher scores mean a worse outcome.
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Time frame: 12 weeks