An interventional study of Qishen Granules and Placebo in Heart Failure with Preserved Ejection Fraction, sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. Recruiting at 2 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine.
Heart failure with preserved ejection fraction (HFpEF) is common and is associated with high morbidity and mor-tality in China. Studies have shown that traditional Chinese medicine (TCM) combined with conventional Western medicine has a good effect on improving exercise tolerance and quality of life in patients with HFpEF, but there are still some shortcomings that limit the reliability and extrapolation of results. Based on TCM theory and our decades of experience, we developed Qishen Granules for therapeutic use in the treatment of HFpEF. The good effect of Qishen Granules in patients with heart failure has been clinically verified before. In this study, cardiopulmonary exercise test (CPET) was used to evaluate the peak oxygen consumption (peak VO2), which is the gold standard assessment of aerobic capacity. Therefore, we selected VO2 peak as the primary outcome. At the same time, we conducted a preliminary assessment of the efficacy of Qishen Granules in improving the quality of life in patients with HFpEF, using Kansas City Cardiomyopathy Questionnaire (KCCQ) as the secondary outcome, and combined with other CPET indicators, echocardiographic measures, NT-pro BNP level, growth STimulation expressed gene 2 (ST2), biomarkers of liver and kidney function, and TCM Four-Dimensional Diagnostic Information Scale (TCMFDIS) to objectively, accurately, and comprehensively evaluate the efficacy and safety of Qishen Granules in improving quality of life and exercise capacity in patients with HFpEF.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 80 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Guangdong Provincial Hospital of Traditional Chinese Medicine is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
On the basis of standardized drug treatment for HFpEF, participants who met the inclusion criteria were randomly given Qishen Granule intervention on the day of inclusion, taking it twice a day for 90 days.
Drug: Qishen Granules
On the basis of standardized drug treatment for HFpEF, participants who met the inclusion criteria were randomly given placebo granules on the day of inclusion, which were taken twice a day for 90 days (the placebo was basically the same as Qishen granules in terms of appearance, shape, color, taste, etc.)
Drug: Placebo
One package per time, twice a day, 90 days of treatment
One package per time, twice a day, 90 days of treatment (the placebo was basically the same as Qishen granules in terms of appearance, shape, color, taste, etc.)
Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90
Measure the efficiency of peak oxygen intake by combining oxygen volume and time to report PeakVO2 in ml/min
Time frame: At enrollment versus at day 90
Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90
Measure the blood flow velocity or motion velocity of specific areas in cm/s
Time frame: At enrollment versus at day 90
Changes in E/e' ratio compared to baseline on day 90
E/e' ratio
Time frame: At enrollment versus at day 90
Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90
Left atrial volume (estimated from echocardiography measurement data) and body surface area (estimated based on height and weight) will be combined to report LAVI in ml/m\^2
Time frame: At enrollment versus at day 90
Changes in Left ventricular mass index (LVMI) compared to baseline on day 90
Left ventricle mass (estimated from echocardiography measurement data) and body surface area (estimated based on height and weight) will be combined to report LVMI in g/m\^2
Time frame: At enrollment versus at day 90
Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90
Calculate the scores of the KCCQ questionnaire
Time frame: At enrollment versus at day 90
Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90
Level of blood NT-proBNP in mmol/L
Time frame: At enrollment versus at day 90
Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90
Level of blood ST2 in mmol/L
Time frame: At enrollment versus at day 90
Changes in blood urea compared to baseline on day 90
Level of blood urea in mmol/L
Time frame: At enrollment versus at day 90
Changes in blood creatinine compared to baseline on day 90
Level of blood creatinine in mmol/L
Time frame: At enrollment versus at day 90
Changes in Aspartate aminotransferase(AST) compared to baseline on day 90
Level of blood AST in mmol/L
Time frame: At enrollment versus at day 90
Changes in Alanine aminotransferase(ALT) compared to baseline on day 90
Level of blood ALT in mmol/L
Time frame: At enrollment versus at day 90
Number of participants with treatment-related adverse events
Assess the incidence of treatment-related adverse events
Time frame: At enrollment versus at day 90
Plan to share: No
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Guangdong Provincial Hospital of Traditional Chinese Medicine