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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT05583773

Run by

China-Japan Friendship Hospital

People needed

336

Starts

2023-03-29

Expected to finish

2025-12-31

Last updated by the study team

2025-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged ≥18 years at the time of consent.
• Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).
• LVEF <50%.
• 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.
• Provision of signed informed consent prior to any study specific procedures.

You may not qualify if…

• 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.
• Uncontrolled severe arrhythmia.
• Planned to undergo heart transplantation or device implantation.
• 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).
• Severe infection.
• eGFR <30 mL/min/1.73 m\^2 by CKD-EPI.
• Active malignancy requiring treatment at the time of visit 1.
• 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.
• 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.
• Systolic blood pressure < 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements.
• Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis.
• Participation in another clinical study.
• 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.

Where it is running

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
• Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine — Beijing, Beijing Municipality, China (enrolling)
• Dongcheng District First People's Hospital — Beijing, Beijing Municipality, China (enrolling)
• Dongfang Hospital Affiliated to Beijing University of Chinese Medicine — Beijing, Beijing Municipality, China (enrolling)
• Huairou District Traditional Chinese Medicine Hospital of Beijing — Beijing, Beijing Municipality, China (enrolling)
• Beijing Changping Nankou Hospital — Beijing, Beijing Municipality, China (enrolling)
• Changping District Traditional Chinese Medicine Hospital — Beijing, Beijing Municipality, China (enrolling)
• Tang County Hospital of Traditional Chinese Medicine — Baoding, Hebei, China (enrolling)
• Funing Hospital of Traditional Chinese Medicine — Qinhuangdao, Hebei, China (enrolling)
• Gongyi City Public Hospital of TCM — Gongyi, Henan, China (enrolling)
• Yangzhou Hospital of Traditional Chinese Medicine — Yangzhou, Jiangsu, China (enrolling)
• Jining Hospital of Traditional Chinese Medicine — Jining, Shandong, China (enrolling)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)
• The Affiliated Hospital of Changzhi Institute of Traditional Chinese Medicine — Changzhi, Shanxi, China (enrolling)
• Changzhi Medical College Affiliated Heji Hospital — Changzhi, Shanxi, China (enrolling)
• Changzhi Hospital of Traditional Chinese Medicine — Changzhi, Shanxi, China (enrolling)
• Chengdu Integrated TCM and Western Medicine Hospital — Chengdu, Sichuan, China (enrolling)
• Jixian Chinese Traditional Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Urumqi Hospital of Traditional Chinese Medicine — Ürümqi, Xinjiang, China (enrolling)
• Korla Hospital of Traditional Chinese Medicine — Bayan Gol Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China (enrolling)
• Changji Hospital of Traditional Chinese Medicine — Changji Hui Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China (enrolling)
• Gulja Hospital of Traditional Chinese Medicine — Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China (enrolling)
• Zhaosu Hospital of Traditional Chinese Medicine — Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China (enrolling)
• Xinyuan Traditional Chinese Medicine Hospital — Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China (enrolling)

Full record on ClinicalTrials.gov

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