Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure
- Conditions
- Chronic Heart Failure With Reduced Ejection Fraction
- Interventions
- Drug: High dose QiShen YiQi Dripping Pills 3 bagsDrug: Low dose QiShen YiQi Dripping Pills 3 bagsDrug: QiShen YiQi Dripping Pills placebo 3 bags
- Registration Number
- NCT04983043
- Lead Sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Brief Summary
This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).
- Detailed Description
QiShen YiQi Dripping Pills are oral, compound traditional chinese medicine prepatations. This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 228
- Conformed to the diagnostic criteria of CHD and chronic heart failure
- Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis
- Male or female subjects aged ≥ 40 years and ≤80 years
- LVEF<45%(modified Simpson method)
- NYHAⅡ-Ⅲ
- Received standardized drug therapy for chronic heart failure at least 2 weeks before randomization, and did not receive intravenous therapy (vasoactive drugs, diuretics) within 2 weeks without adjustment of dose
- Ability to understand the requirements of the study and willingness to provide written informed consent
- Have no pregnancy program and take effective contraceptive measures voluntarily
- Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment
- Patients with heart failure caused by other heart diseases,such as cor pulmonale, congenital heart disease, primary pulmonary hypertension, secondary severe pulmonary hypertension, severe stenosis or insufficiency of heart valves, cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion, constrictive pericarditis, infective endocarditis
- Heart failure caused by systemic diseases or other systemic diseases, such as rheumatic immune and secretory diseases;heart failure caused by kidney disease, lung disease, liver disease and serious infection;heart failure caused by chemical or toxicological causes
- Patients who had acute myocardial infarction, underwent coronary revascularization or left ventricular remodeling, underwent cardiac resynchronization with pacemaker implantation, underwent cardiothoracic surgery within 3 months prior to receiving the experimental drug, patients with other acute coronary syndrome, pulmonary embolism or acute cerebrovascular disease
- Severe arrhythmias such as ventricular tachycardia, second degree Ⅱ type or above sinus atrial or atrioventricular block without pacemaker treatment, average QTc > 500ms, heart rate < 50 beats/min, etc
- Complicated with other serious diseases, such as pheochromocytoma, hematologic diseases, organ transplantation patients, and any history of malignant tumor
- The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg
- Hypotension with a systolic blood pressure <80mmHg and/or a diastolic blood pressure <50mmHg
- Patients with hepatic and/or renal dysfunction (ALT≥ 2 times the upper limit of normal, and/or estimated glomerular filtration rate (EGFR) <30 mL /min/1.73m2
- HbA1c ≥9.0%, or fasting blood glucose ≥13.9mmol/L
- Moderate and severe anemia (Hb < 90g/L)
- Serum potassium ≥5.5mmol/L
- Patients requiring anticoagulants who did not achieve dose stabilization for 1 month or INR > 3.0
- In patients who need to take antiplatelet drugs, the dose was stable for less than 1 month, and the platelet value was lower than the lower limit of normal value
- Allergic to the test drug or its related taste or ingredients
- People with complicated mental illness, poor condition control and drug addiction
- Unable to complete 6MWT
- Pregnant or lactating women
- Participation in other studies and use of investigational drugs from other studies within 3 months prior to screening
- The investigator deems that the patient is not suitable to participate in the study, including the investigator's judgment that the patient is unable to complete the study or comply with the requirements of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose group High dose QiShen YiQi Dripping Pills 3 bags High dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day Low dose group Low dose QiShen YiQi Dripping Pills 3 bags Low dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day Placebo group QiShen YiQi Dripping Pills placebo 3 bags QiShen YiQi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
- Primary Outcome Measures
Name Time Method 6-Minutes-Walking-Test (6MWT) in week 12 Baseline to weeks 12 Change from baseline to weeks 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
- Secondary Outcome Measures
Name Time Method 6-Minutes-Walking-Test (6MWT) in weeks 4 and 8 Baseline to weeks 4 and 8 Change from baseline to weeks 4 and 8 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
Cardiovascular adverse events Week 12 To determine whether the incidence of cardiovascular adverse events during the study period was superior to placebo.
Echocardiogram results Baseline to weeks 4,8 and 12 1. Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic diameter(LVEDD) measured by echocardiography;
2. Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic volume(LVEDV) measured by echocardiography;
3. Change from baseline to weeks 4,8 and 12 in left ventricular end systolic volume(LVESV) measured by echocardiography;
4. Change from baseline to weeks 4,8 and 12 in left ventricular ejection fraction(LVEF) measured by echocardiography;
5. Change from baseline to weeks 4,8 and 12 in stroke volume(SV) measured by echocardiography;
6. Change from baseline to weeks 4,8 and 12 in cardiac output(CO) measured by echocardiography.NYHA classification Baseline to weeks 4,8 and 12 Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.
Traditional Chinese Medicine Syndrome Score Baseline to weeks 4,8 and 12 Change from baseline to weeks 4,8 and 12 in Traditional Chinese Medicine Syndrome Score. There were 3 clinical primary symptoms, 4 clinical secondary symptoms, tongue picture and pulse condition evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM primary symptoms scored as without 0, light 2, medium 4, heavy 6 points. The standard of TCM secondary symptoms scored as without 0, with 1 points. Tongue picture and pulse condition did not count.
Dyspnea, weakness, edema Baseline to weeks 4,8 and 12 Symptom disappearance rate(dyspnea, weakness, edema) from baseline to weeks 4,8 and 12.
NT-proBNP Baseline to weeks 4,8 and 12 Change from baseline to weeks 4,8 and 12 in NT-proBNP.
Minnesota Living With Heart Failure Questionnaire(MLHFQ) Baseline to weeks 4,8 and 12 Change from baseline to weeks 4,8 and 12 in Minnesota Living With Heart Failure Questionnaire(MLHFQ). The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items representing different degrees of impact of HF on health-related quality of life. Every item in this questionnaire scores from 0 (none) to 5 (very much) and the total items score from 0 (none) to 105 (very much).
Trial Locations
- Locations (23)
Hefei First People's Hospital
🇨🇳Hefei, Anhui, China
The First Hospital of ANHUI University of Science & Technology
🇨🇳Huainan, Anhui, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Anhui, China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China
Xiamen Hospital of Traditional Chinese Medicine
🇨🇳Xiamen, Fujian, China
Dongguan TCM Hospital
🇨🇳Dongguan, Guangdong, China
Nanfang Hospital，Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Affiliated TCM Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Zhong Shan Hospital of Chinese Medicine
🇨🇳Zhongshan, Guangdong, China
Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
🇨🇳Harbin, Heilongjiang, China
Luoyang Third People's Hospital
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, Henan, China
Pepole's Hospital of Xinzheng
🇨🇳Zhengzhou, Henan, China
Hunan University of Chinese Medicine
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
Nanjing Hospital of Traditional Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
🇨🇳Shenyang, Liaoning, China
Xi'an Daxing Hospital
🇨🇳Xi'an, Shaanxi, China
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
🇨🇳Chengdu, Sichuan, China
The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine
🇨🇳Tianjin, Tianjin, China
Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
🇨🇳Ürümqi, Xinjiang, China