Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377761
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2022-06-02
Brief Title:
Study on Heart Failure With Preserved Ejection Fraction With Qishen Granules
Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Organization:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study on the Treatment of Heart Failure With Preserved Ejection Fraction With Qishen Granules Based on Cardiopulmonary Exercise Test
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None