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Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Reduced Ejection Fraction (Syndrome of Qi Deficiency and Blood Stasis) Due to Coronary Heart Disease

Primary Purpose

Chronic Heart Failure With Reduced Ejection Fraction

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Low dose Qishenyiqi Dripping Pills 3 bags
High dose Qishenyiqi Dripping Pills 3 bags
Qishenyiqi Dripping Pills placebo 3 bags
Sponsored by
Tasly Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting
  • Xiamen Hospital of Traditional Chinese MedicineRecruiting
  • The Affiliated TCM Hospital of Guangzhou Medical UniversityRecruiting
  • The First Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting
  • Zhong Shan Hospital of Chinese MedicineRecruiting
  • Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese MedicineRecruiting
  • The First Affiliated Hospital of Heilongjiang University of Chinese MedicineRecruiting
  • The First Affiliated Hospital of Nanyang Medical CollegeRecruiting
  • Pepole's Hospital of XinzhengRecruiting
  • Hunan University of Chinese MedicineRecruiting
  • The First Affiliated Hospital of University of South ChinaRecruiting
  • Nanjing Hospital of Traditional Chinese MedicineRecruiting
  • The Affiliated Hospital of Liaoning University of Traditional Chinese MedicineRecruiting
  • The Affiliated Hospital of Chengdu University of Traditional Chinese MedicineRecruiting
  • The Second Affiliated Hospital of Tianjin University of traditional Chinese MedicineRecruiting
  • Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose group

High dose group

Placebo group

Arm Description

Low dose Qishenyiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day

High dose Qishenyiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day

Qishenyiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
NYHA classification
Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from 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.
Dyspnea, weakness, edema
Symptom disappearance rate(dyspnea, weakness, edema) from 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.
NT-proBNP
Change from baseline to weeks 4,8 and 12 in NT-proBNP.
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).
Cardiovascular adverse events
To determine whether the incidence of cardiovascular adverse events during the study period was superior to placebo.

Full Information

First Posted
July 8, 2021
Last Updated
November 14, 2022
Sponsor
Tasly Pharmaceutical Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04983043
Brief Title
Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Reduced Ejection Fraction (Syndrome of Qi Deficiency and Blood Stasis) Due to Coronary Heart Disease
Official Title
A Multi-center, Randomized, Double-blind, Placebo-parallel Controlled, Standardise-loaded Ⅱ Clinical Trial of Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Reduced Ejection Fraction (Syndrome of Qi Deficiency and Blood Stasis) Due to Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety and the best effective dose of Qishen Yiqi Drop Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure With Reduced Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose group
Arm Type
Experimental
Arm Description
Low dose Qishenyiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Arm Title
High dose group
Arm Type
Experimental
Arm Description
High dose Qishenyiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Qishenyiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
Intervention Type
Drug
Intervention Name(s)
Low dose Qishenyiqi Dripping Pills 3 bags
Other Intervention Name(s)
Low dose group
Intervention Description
Low dose Qishenyiqi Dripping Pills contain Qishenyiqi dripping pills 2 bags(0.52g dripping pills per bag) and Qishenyiqi dripping pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
Intervention Type
Drug
Intervention Name(s)
High dose Qishenyiqi Dripping Pills 3 bags
Other Intervention Name(s)
High dose group
Intervention Description
High dose Qishenyiqi Dripping Pills contain Qishenyiqi dripping pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
Intervention Type
Drug
Intervention Name(s)
Qishenyiqi Dripping Pills placebo 3 bags
Other Intervention Name(s)
Placebo group
Intervention Description
Qishenyiqi Dripping Pills placebo contain Qishenyiqi dripping pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
Primary Outcome Measure Information:
Title
6-Minutes-Walking-Test (6MWT) in week 12
Description
Change from baseline to weeks 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
Time Frame
Baseline to weeks 12
Secondary Outcome Measure Information:
Title
6-Minutes-Walking-Test (6MWT) in weeks 4 and 8
Description
Change from baseline to weeks 4 and 8 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
Time Frame
Baseline to weeks 4 and 8
Title
NYHA classification
Description
Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.
Time Frame
Baseline to weeks 4,8 and 12
Title
Traditional Chinese Medicine Syndrome Score
Description
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.
Time Frame
Baseline to weeks 4,8 and 12
Title
Dyspnea, weakness, edema
Description
Symptom disappearance rate(dyspnea, weakness, edema) from baseline to weeks 4,8 and 12.
Time Frame
Baseline to weeks 4,8 and 12
Title
Echocardiogram results
Description
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.
Time Frame
Baseline to weeks 4,8 and 12
Title
NT-proBNP
Description
Change from baseline to weeks 4,8 and 12 in NT-proBNP.
Time Frame
Baseline to weeks 4,8 and 12
Title
Minnesota Living With Heart Failure Questionnaire(MLHFQ)
Description
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).
Time Frame
Baseline to weeks 4,8 and 12
Title
Cardiovascular adverse events
Description
To determine whether the incidence of cardiovascular adverse events during the study period was superior to placebo.
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Saturation of Peripheral Oxygen
Description
To determine whether the saturation of peripheral oxygen is improved from baseline to week 12 after treatment.
Time Frame
Week 12
Title
Grasp strength body mass index test
Description
To determine whether the grasp strength body mass index is improved from baseline to week 12 after treatment.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Liu
Phone
022-86343626
Email
liurui2@tasly.com
Facility Information:
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li
Facility Name
Xiamen Hospital of Traditional Chinese Medicine
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianfa Chen
Facility Name
The Affiliated TCM Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suilin Ye
Facility Name
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongqi Yang
Facility Name
Zhong Shan Hospital of Chinese Medicine
City
Zhongshan
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueshan Li
Facility Name
Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingsong He
Facility Name
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Liu
Facility Name
The First Affiliated Hospital of Nanyang Medical College
City
Nanyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li
Facility Name
Pepole's Hospital of Xinzheng
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangjun Wang
Facility Name
Hunan University of Chinese Medicine
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yilin Mao
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Wu
Facility Name
Nanjing Hospital of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Gu
Facility Name
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Hou
Facility Name
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Yao
Facility Name
The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Xu
Facility Name
Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
City
Ürümqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Li

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Reduced Ejection Fraction (Syndrome of Qi Deficiency and Blood Stasis) Due to Coronary Heart Disease

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