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

Chronic Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04983043
• Other study ID #: TSL-TCM-QSYQDW-HFrEF-?
• Status: Recruiting
• Phase: Phase 2
• Start date: June 10, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: Rui Liu
• Phone: 022-86343626
• Email: liurui2[@]tasly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

• NYHA?-?

• 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 ? 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

Related Conditions & MeSH terms

• Chronic Heart Failure With Reduced Ejection Fraction
• Heart Failure

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing
China	Hunan University of Chinese Medicine	Changsha	Hunan
China	The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan
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	The First Affiliated Hospital of Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang
China	Hefei First People's Hospital	Hefei	Anhui
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan
China	The First Hospital of ANHUI University of Science & Technology	Huainan	Anhui
China	Luoyang Third People's Hospital	Luoyang	Henan
China	Nanjing Hospital of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine	Nanning	Guangxi
China	The First Affiliated Hospital of Nanyang Medical College	Nanyang	Henan
China	The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning
China	Suzhou Municipal Hospital	Suzhou	Anhui
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	Xi'an Daxing Hospital	Xi'an	Shaanxi
China	Xiamen Hospital of Traditional Chinese Medicine	Xiamen	Fujian
China	Pepole's Hospital of Xinzheng	Zhengzhou	Henan
China	Zhong Shan Hospital of Chinese Medicine	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Saturation of Peripheral Oxygen	To determine whether the saturation of peripheral oxygen is improved from baseline to week 12 after treatment.	Week 12
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Dyspnea, weakness, edema	Symptom disappearance rate(dyspnea, weakness, edema) from baseline to weeks 4,8 and 12.	Baseline to weeks 4,8 and 12
Secondary	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
Secondary	NT-proBNP	Change from baseline to weeks 4,8 and 12 in NT-proBNP.	Baseline to weeks 4,8 and 12
Secondary	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
Secondary	Cardiovascular adverse events	To determine whether the incidence of cardiovascular adverse events during the study period was superior to placebo.	Week 12