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SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction

Study acronym: SHINE-HF
StatusRecruiting
PhasePhase 4
Started2023-03-29
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 8, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-04-04
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations, IPDSharing v11
Primary completion date2025-04-30→2025-08-31
Study sites21→26
Eligibility criteria+1 characters
[...] sis of symptomatic HFrEF (NYHA functional class II-IV). LVEF≤ <50%. NT-proBNP >600 pg/ml or BNP ≥150 pg/ml (or if hospitali [...]
Study description+14 characters
This is a pragmatic, nationwide, multicenter, parallel group, randomized, double [...] ontrolled study in patients with heart failure with reduced and mildly ejection fraction (HFrEF), evaluating the effect of "ShengXian-QuYu Decoction" versus [...]
Study title+2 characters
SHengXIaN-QuYu DEcoction in the Treatment of Heart Failure withWith Reduced and Mildly Reduced Ejection Fraction
2024-09-16
Study Identification, Study Status, Conditions, Arms and Interventions, Contacts/Locations v10
Study sites17→21
Study titlerevised
SHengXIaN-QuYu DEcoction in the Treatment of Heart Failure Withwith Reduced Ejection Fraction
2024-07-27
Study Status, Study Design v9
Enrollment target564→336
2024-02-02
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility v8
InterventionsPlacebo (Other), Shengxian Quyu Decoction (Drug)→Placebo (Other), ShengXian-QuYu Decoction (Drug)
Eligibility criteriarevised
[...] sis of symptomatic HFrEF (NYHA functional class II-IV). LVEF<40≤50%. NT-proBNP >600 pg/ml or BNP ≥150 pg/ml (or if hospitalize [...]
Study description+13 characters
This is a nationwide, multicenter, prospectiveparallel group, randomisedrandomized, double-blind, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction (HFrEF), evaluating the effect of "Shengxian QuyuShengXian-QuYu Decoction" versus placebo, given twice daily in addition to background regional standard of care therapy. The effect of "Shengxian QuyuShengXian-QuYu Decoction"on quality of life, symptoms and biomarkers will [...]
2024-01-27
Study Identification, Study Status, Study Design, Contacts/Locations v7
Enrollment target308→564
Study sites4→17
Study titlerevised
ShengxianSHengXIaN-QuYu Quyu DecoctionDEcoction in the Treatment of Heart Failure With Reduced Ejection Fraction
Show 6 earlier versions
2023-05-09
Study Status, Outcome Measures, Contacts/Locations v6
Study sites3→4
Secondary endpoints9 entries, revised
Change From Baseline in the KCCQ TotalClinical SymptomSummary Score
Primary endpoints1 entry, revised
Change From Baseline in the KCCQ TotalClinical SymptomSummary Score
2023-04-11
Study Status, Arms and Interventions, Contacts/Locations v5
Study sites2→3
2023-04-08
Study Status, Contacts/Locations v4
Study sites1→2
2023-03-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-02-07→confirmed 2023-03-29
Study sites0→1
2023-02-07
Study Status v2
Start date2022-12-10→2023-02-07
2022-12-08
Study Status v1
Start date2022-11-01→2022-12-10
2022-10-13
Original filing
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 and mildly reduced ejection fraction.
Trial Details
NCT Number NCT05583773
Lead Sponsor China-Japan Friendship Hospital
Conditions Heart Failure
Enrollment 336 participants
Start Date 2023-03-29
Primary Completion 2025-08-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-08