Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

A Multi-center, Randomized, Double-blind, Placebo-parallel Controlled, Standardise-loaded Ⅱ Clinical Trial of Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Drug: Low dose QiShen YiQi Dripping Pills 3 bags; Drug: High dose QiShen YiQi Dripping Pills 3 bags; Drug: QiShen YiQi Dripping Pills placebo 3 bags

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).

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rui Liu; Phone Number: 022-86343626; Email: liurui2@tasly.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • Hefei First People's Hospital
      • Contact: Xiaohong Zhang
    • Huainan, Anhui, China
      • Recruiting
      • The First Hospital of ANHUI University of Science & Technology
      • Contact: Lijun Liu
    • Suzhou, Anhui, China
      • Recruiting
      • Suzhou Municipal Hospital
      • Contact: Hailong Qiu
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
      • Contact: Jun Li
  • Fujian
    • Xiamen, Fujian, China
      • Recruiting
      • Xiamen Hospital of Traditional Chinese Medicine
      • Contact: Lianfa Chen
  • Guangdong
    • Dongguan, Guangdong, China
      • Recruiting
      • Dongguan TCM Hospital
      • Contact: Jianfeng Ye
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Contact: Zhongqi Yang
    • Guangzhou, Guangdong, China
      • Recruiting
      • Nanfang Hospital，Southern Medical University
      • Contact: Qingchun Zeng
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Affiliated TCM Hospital of Guangzhou Medical University
      • Contact: Suilin Ye
    • Zhongshan, Guangdong, China
      • Recruiting
      • Zhong Shan Hospital of Chinese Medicine
      • Contact: Xueshan Li
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine
      • Contact: Jingsong He
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
      • Contact: Li Liu
  • Henan
    • Luoyang, Henan, China
      • Recruiting
      • Luoyang Third People's Hospital
      • Contact: Lipeng Li
    • Nanyang, Henan, China
      • Recruiting
      • The First affiliated Hospital of Nanyang Medical College
      • Contact: Jie Li
    • Zhengzhou, Henan, China
      • Recruiting
      • Pepole's Hospital of Xinzheng
      • Contact: Guangjun Wang
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan University of Chinese Medicine
      • Contact: Yilin Mao
    • Hengyang, Hunan, China
      • Recruiting
      • The First Affiliated Hospital of University of South China
      • Contact: Jie Wu
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Hospital of Traditional Chinese Medicine
      • Contact: Ning Gu
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
      • Contact: Ping Hou
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • Xi'an Daxing Hospital
      • Contact: Zhili Li
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
      • Contact: Ping Yao
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
      • Contact: Qiang Xu
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Recruiting
      • Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
      • Contact: Peng Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose group; Low dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day	Drug: Low dose QiShen YiQi Dripping Pills 3 bags; Low dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 2 bags(0.52g dripping pills per bag) and QiShen YiQi Dripping Pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks; Other Names: Low dose group
Experimental: High dose group; High dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day	Drug: High dose QiShen YiQi Dripping Pills 3 bags; High dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks; Other Names: High dose group
Placebo Comparator: Placebo group; QiShen YiQi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day	Drug: QiShen YiQi Dripping Pills placebo 3 bags; QiShen YiQi Dripping Pills placebo contain QiShen YiQi Dripping Pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks; Other Names: Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minutes-Walking-Test (6MWT) in week 12	Change from baseline to weeks 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.	Baseline to weeks 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minutes-Walking-Test (6MWT) in 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.	Baseline to weeks 4 and 8
NYHA classification	Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.	Baseline to weeks 4,8 and 12
Traditional Chinese Medicine Syndrome Score	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.	Baseline to weeks 4,8 and 12
Dyspnea, weakness, edema	Symptom disappearance rate(dyspnea, weakness, edema) from baseline to weeks 4,8 and 12.	Baseline to weeks 4,8 and 12
Echocardiogram results	Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic diameter(LVEDD) measured by echocardiography;; Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic volume(LVEDV) measured by echocardiography;; Change from baseline to weeks 4,8 and 12 in left ventricular end systolic volume(LVESV) measured by echocardiography;; Change from baseline to weeks 4,8 and 12 in left ventricular ejection fraction(LVEF) measured by echocardiography;; Change from baseline to weeks 4,8 and 12 in stroke volume(SV) measured by echocardiography;; Change from baseline to weeks 4,8 and 12 in cardiac output(CO) measured by echocardiography.	Baseline to weeks 4,8 and 12
NT-proBNP	Change from baseline to weeks 4,8 and 12 in NT-proBNP.	Baseline to weeks 4,8 and 12
Minnesota Living With Heart Failure Questionnaire(MLHFQ)	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).	Baseline to weeks 4,8 and 12
Cardiovascular adverse events	To determine whether the incidence of cardiovascular adverse events during the study period was superior to placebo.	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saturation of Peripheral Oxygen	To determine whether the saturation of peripheral oxygen is improved from baseline to week 12 after treatment.	Week 12
Grasp strength body mass index test	To determine whether the grasp strength body mass index is improved from baseline to week 12 after treatment.	Week 12

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: TSL-TCM-QSYQDW-HFrEF-Ⅱ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No