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Recruiting Phase 4 NCT05583773

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

Trial Parameters

Condition Heart Failure
Sponsor China-Japan Friendship Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 336
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-03-29
Completion 2025-08-31
Interventions
ShengXian-QuYu DecoctionPlacebo

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 and mildly reduced ejection fraction.

Eligibility Criteria

Inclusion Criteria: 1. Male or female, aged ≥18 years at the time of consent. 2. Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV). 3. LVEF \<50%. 4. NT-proBNP \>600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment. 5. Provision of signed informed consent prior to any study specific procedures. Exclusion Criteria: 1. Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment. 2. Uncontrolled severe arrhythmia. 3. Planned to undergo heart transplantation or device implantation. 4. Hepatic impairment aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \>3x the upper lim

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