Clinical trial NCT04983043: Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Heart Failure With Reduced Ejection Fraction
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 228
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: 6-Minutes-Walking-Test (6MWT) in week 12
timeFrame: Baseline to weeks 12
Secondary outcomes:
measure: 6-Minutes-Walking-Test (6MWT) in weeks 4 and 8
timeFrame: Baseline to weeks 4 and 8
measure: NYHA classification
timeFrame: Baseline to weeks 4,8 and 12
measure: Traditional Chinese Medicine Syndrome Score
timeFrame: Baseline to weeks 4,8 and 12
measure: Dyspnea, weakness, edema
timeFrame: Baseline to weeks 4,8 and 12
measure: Echocardiogram results
timeFrame: Baseline to weeks 4,8 and 12
measure: NT-proBNP
timeFrame: Baseline to weeks 4,8 and 12
measure: Minnesota Living With Heart Failure Questionnaire(MLHFQ)
timeFrame: Baseline to weeks 4,8 and 12
measure: Cardiovascular adverse events
timeFrame: Week 12
Other outcomes:
measure: Saturation of Peripheral Oxygen
timeFrame: Week 12
measure: Grasp strength body mass index test
timeFrame: Week 12
Locations:
city: Hefei
country: China
facility: Hefei First People's Hospital
state: Anhui
city: Huainan
country: China
facility: The First Hospital of ANHUI University of Science & Technology
state: Anhui
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Anhui
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Xiamen
country: China
facility: Xiamen Hospital of Traditional Chinese Medicine
state: Fujian
city: Dongguan
country: China
facility: Dongguan TCM Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital，Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Affiliated TCM Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Zhongshan
country: China
facility: Zhong Shan Hospital of Chinese Medicine
state: Guangdong
city: Nanning
country: China
facility: Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine
state: Guangxi
city: Harbin
country: China
facility: The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Zhengzhou
country: China
facility: Pepole's Hospital of Xinzheng
state: Henan
city: Changsha
country: China
facility: Hunan University of Chinese Medicine
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Nanjing
country: China
facility: Nanjing Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Shenyang
country: China
facility: The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Xi'an
country: China
facility: Xi'an Daxing Hospital
state: Shaanxi
city: Chengdu
country: China
facility: The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Tianjin
country: China
facility: The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine
state: Tianjin
city: Ürümqi
country: China
facility: Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
state: Xinjiang
Study officials:
References: