Trials / Recruiting
RecruitingNCT05583773
SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction
Effects of "ShengXian-QuYu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced and Mildly Reduced Ejection Fraction: a Pragmatic, Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 336 (estimated)
- Sponsor
- China-Japan Friendship Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 and mildly reduced ejection fraction.
Detailed description
This is a pragmatic, nationwide, multicenter, parallel group, randomized, double-blind, placebo-controlled study in patients with heart failure with reduced and mildly ejection fraction, 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 Decoction"on 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ShengXian-QuYu Decoction | Specification: 30ml/bag, given twice daily, per oral use. |
| OTHER | Placebo | Placebo matching ShengXian-QuYu Decoction, 30ml/bag, given twice daily, per oral use. |
Timeline
- Start date
- 2023-03-29
- Primary completion
- 2025-08-31
- Completion
- 2025-12-31
- First posted
- 2022-10-18
- Last updated
- 2025-04-08
Locations
26 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05583773. Inclusion in this directory is not an endorsement.