SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction
Recruiting · NCT05583773 · Interventional (participants receive a specific treatment) · Lead sponsor: China-Japan Friendship Hospital
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboShengXian-QuYu Decoction
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
26 locations listed.
- China-Japan Friendship Hospital - Beijing, Beijing Municipality, China
- Peking University People's Hospital - Beijing, Beijing Municipality, China
- Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine - Beijing, Beijing Municipality, China
- Dongcheng District First People's Hospital - Beijing, Beijing Municipality, China
- Dongfang Hospital Affiliated to Beijing University of Chinese Medicine - Beijing, Beijing Municipality, China
- Huairou District Traditional Chinese Medicine Hospital of Beijing - Beijing, Beijing Municipality, China
- Beijing Changping Nankou Hospital - Beijing, Beijing Municipality, China
- Changping District Traditional Chinese Medicine Hospital - Beijing, Beijing Municipality, China
- Tang County Hospital of Traditional Chinese Medicine - Baoding, Hebei, China
- Funing Hospital of Traditional Chinese Medicine - Qinhuangdao, Hebei, China
- Gongyi City Public Hospital of TCM - Gongyi, Henan, China
- Yangzhou Hospital of Traditional Chinese Medicine - Yangzhou, Jiangsu, China
- Jining Hospital of Traditional Chinese Medicine - Jining, Shandong, China
- The Affiliated Hospital of Qingdao University - Qingdao, Shandong, China
- The Affiliated Hospital of Changzhi Institute of Traditional Chinese Medicine - Changzhi, Shanxi, China
- Changzhi Medical College Affiliated Heji Hospital - Changzhi, Shanxi, China
- Changzhi Hospital of Traditional Chinese Medicine - Changzhi, Shanxi, China
- Chengdu Integrated TCM and Western Medicine Hospital - Chengdu, Sichuan, China
- Jixian Chinese Traditional Hospital - Tianjin, Tianjin Municipality, China
- Urumqi Hospital of Traditional Chinese Medicine - Ürümqi, Xinjiang, China
- Korla Hospital of Traditional Chinese Medicine - Bayan Gol Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China
- Changji Hospital of Traditional Chinese Medicine - Changji Hui Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China
- Gulja Hospital of Traditional Chinese Medicine - Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China
- Zhaosu Hospital of Traditional Chinese Medicine - Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China
- Xinyuan Traditional Chinese Medicine Hospital - Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China
- Linhai Hospital of Traditional Chinese Medicine - Linhai, Zhejiang, China