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โ† Trials
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SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction

RecruitingPhase 4Ages 18 Years - anyAllChina-Japan Friendship Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female, aged โ‰ฅ18 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 โ‰ฅ150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP โ‰ฅ400 pg/ml or BNP โ‰ฅ100 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 limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment). 5. Severe infection. 6. eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI. 7. Active malignancy requiring treatment at the time of visit 1. 8. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding. 9. Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement. 10. Systolic blood pressure \< 90 mmHg, or systolic blood pressure โ‰ฅ 180 mmHg, or diastolic blood pressure โ‰ฅ 110 mmHg on 2 consecutive measurements. 11. Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis. 12. Participation in another clinical study. 13. Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
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What it tests

  • ShengXian-QuYu Decoction
  • Placebo
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Where

26 sites
China-Japan Friendship Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine
Beijing, China
Dongcheng District First People's Hospital
Beijing, China
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, China
Huairou District Traditional Chinese Medicine Hospital of Beijing
Beijing, China
Beijing Changping Nankou Hospital
Beijing, China
Changping District Traditional Chinese Medicine Hospital
Beijing, China

โ€ฆand 18 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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