SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction
- Conditions
- Heart Failure
- Interventions
- Drug: ShengXian-QuYu DecoctionOther: Placebo
- Registration Number
- NCT05583773
- Lead Sponsor
- China-Japan Friendship Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 336
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ShengXian-QuYu Decoction ShengXian-QuYu Decoction Patients will be randomized 1:1 to either ShengXian-QuYu Decoction or placebo. "ShengXian-QuYu Decoction" (calculated by a medicine): 30g of Astragalus membranaceus (Huangqi), 12g of Cornus officinalis (Shanzhuyu), 9g of Panax ginseng (Hongshen), 12g of Anemarrhena asphodeloides (Zhimu), 8g of Cimicifuga foetida (Shengma), 8g of Bupleurum chinense (Chaihu), 10g of Platycodon grandiflorum (Jiegeng), 10g of Sparganium stoloniferum (Sanleng), 9g of Curcuma phaeocaulis (Ezhu), 3g of Whitmania pigra (Shuizhi). placebo Placebo Placebo matching ShengXian-QuYu Decoction
- Primary Outcome Measures
Name Time Method Change From Baseline in the KCCQ Clinical Summary Score Up to 12 weeks KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) Up to 26 weeks Traditional Chinese Medicine Syndrome Score is a instrument that quantifies symptoms. Lower TCM scores reflect better health status.
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance Up to 12 weeks Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication.
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Up to 12 weeks Change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NT-proBNP). Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.
Change in Left Ventricular Systolic Function Up to 12 weeks Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography.
Change in Left Ventricular End-Diastolic Diameter Up to 12 weeks Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Change in Left Ventricular End-Systolic Diameter Up to 12 weeks Change in left ventricular end-systolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Change in Estimated Glomerular Filtration Rate from Baseline Up to 12 weeks Estimated glomerular filtration rate (eGFR) is calculated by the CKD-EPI equation.
Change From Baseline in the KCCQ Clinical Summary Score Up to 26 weeks KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Trial Locations
- Locations (26)
Yangzhou Hospital of Traditional Chinese Medicine
🇨🇳Yangzhou, Jiangsu, China
Changzhi Medical College Affiliated Heji Hospital
🇨🇳Changzhi, Shanxi, China
Changzhi Hospital of Traditional Chinese Medicine
🇨🇳Changzhi, Shanxi, 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
Dongcheng District First People's Hospital
🇨🇳Beijing, Beijing, China
Tang County Hospital of Traditional Chinese Medicine
🇨🇳Baoding, Hebei, China
Gongyi City Public Hospital of TCM
🇨🇳Gongyi, Henan, 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
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine
🇨🇳Beijing, Beijing, China
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China
Huairou District Traditional Chinese Medicine Hospital of Beijing
🇨🇳Beijing, Beijing, China
Beijing Changping Nankou Hospital
🇨🇳Beijing, Beijing, China
Changping District Traditional Chinese Medicine Hospital
🇨🇳Beijing, Beijing, China
Funing Hospital of Traditional Chinese Medicine
🇨🇳Qinhuangdao, Hebei, 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
Chengdu Integrated TCM and Western Medicine Hospital
🇨🇳Chengdu, Sichuan, China
Jixian Chinese Traditional Hospital
🇨🇳Tianjin, Tianjin, China
Urumqi Hospital of Traditional Chinese Medicine
🇨🇳Urumqi, Xinjiang, China
Linhai Hospital of Traditional Chinese Medicine
🇨🇳Linhai, Zhejiang, China