Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05583773
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2022-10-08
Brief Title:
SHengXIaN-QuYu DEcoction in the Treatment of Heart Failure with Reduced Ejection Fraction
Sponsor:
China-Japan Friendship Hospital
Organization:
China-Japan Friendship Hospital
Study Overview
Official Title:
Effects of ShengXian-QuYu Decoction on Quality of Life Symptoms and Biomarkers in Heart Failure Patients with Reduced Ejection Fraction a Nationwide Multicenter Parallel Group Randomized Double-Blind Placebo-Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
SHINE-HF
Brief Summary:
The purpose of this study is to conduct a multicenter randomized clinical trial to evaluate the effect of ShengXian-QuYu Decoction on quality of life symptoms and biomarkers in heart failure patients with reduced ejection fraction
Detailed Description:
This is a nationwide multicenter parallel group randomized double-blind placebo-controlled study in patients with heart failure with reduced ejection fraction HFrEF evaluating the effect of ShengXian-QuYu Decoction versus placebo given twice daily in addition to background regional standard of care The effect of ShengXian-QuYu Decoctionon quality of life symptoms and biomarkers will be evaluated
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography heart failure characteristics Traditional Chinese Medicine syndrome type diabetes status kidney function left ventricular ejection fraction natriuretic peptide and additional co-morbidities concomitant medications and others
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography heart failure characteristics Traditional Chinese Medicine syndrome type diabetes status kidney function left ventricular ejection fraction natriuretic peptide and additional co-morbidities concomitant medications and others
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?:
False
Is an FDA AA801 Violation?:
None