Back to resultsthe Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
YanXinShi placebo pills
YanXinShi pills
Trimetazidine pills
YanXinShi and Trimetazidine pills
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure
Eligibility Criteria
Inclusion Criteria:
- patients newly diagnosed with heart failure or have been diagnosed with chronic heart failure
- patients classified as NYHA II-IV (New York Heart Association)
Exclusion Criteria:
- with severe liver or renal dysfunction
- with severe systematic conditions such as infection, malignant hypertension etc.
- hemodynamic instability (arrhythmia, acute cardiac infarction, aortic dissection etc.)
- not cooperating due to psychomotor deficiency, or with contraindications for exercise testing
Sites / Locations
- Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Active Comparator
Other
Arm Label
the control group
YanXinShi group
Trimetazidine group
YangXinShi and Trimetazidine group
Arm Description
YanXinShi placebo pills
YanXinShi pills
Trimetazidine pills
YanXinShi and Trimetazidine pills
Outcomes
Primary Outcome Measures
change in EQ-5D Questionnaire
health status measured in therms of five dimensions with the 5-level scale from 1-5, corresponding to having no problems and having extreme problems
change in EQ-VAS
visual analogue scale (VAS) of EQ-5D Questionnaire scaled from 0-100, corresponding to the worse and the best health imagined
Secondary Outcome Measures
change in disease specific quality of life
assessment of disease-related QoL using Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 7 heart failure domains. Scores of each domain are scaled from 0-100, with 0 corresponding to the worst, 100 the best status.
change in heart rate variability
assessed by Holter monitoring
change in left ventricular end-systolic diameters (in millimeters)
assessed by echocardiographic examination
change in left ventricular end-diastolic diameters (in millimeters)
assessed by echocardiographic examination
change in left ventricular ejection fraction (in percentage)
assessed by echocardiographic examination
change in exercise tolerance
assessed by the distance (in meters) walked on 6-minute walk test
change in metabolic equivalents (METs)
measured as (volume of O2 (ml) consumption/kg/min) / (3.5 ml VO2/kg/min)
change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (in pg/ml)
assessed by blood tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03333499
Brief Title
the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure
Official Title
the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalian University
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
The investigators set out to evaluate the effects of the traditional Chinese medicinal mixture under the brand name YangXinShi (YXS) on the prognosis in patients with chronic heart failure when it is combined with the optimal combination drug treatment of heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the control group
Arm Type
Placebo Comparator
Arm Description
YanXinShi placebo pills
Arm Title
YanXinShi group
Arm Type
Experimental
Arm Description
YanXinShi pills
Arm Title
Trimetazidine group
Arm Type
Active Comparator
Arm Description
Trimetazidine pills
Arm Title
YangXinShi and Trimetazidine group
Arm Type
Other
Arm Description
YanXinShi and Trimetazidine pills
Intervention Type
Drug
Intervention Name(s)
YanXinShi placebo pills
Intervention Description
participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure
Intervention Type
Drug
Intervention Name(s)
YanXinShi pills
Intervention Description
participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure
Intervention Type
Drug
Intervention Name(s)
Trimetazidine pills
Intervention Description
participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
Intervention Type
Drug
Intervention Name(s)
YanXinShi and Trimetazidine pills
Intervention Description
participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
Primary Outcome Measure Information:
Title
change in EQ-5D Questionnaire
Description
health status measured in therms of five dimensions with the 5-level scale from 1-5, corresponding to having no problems and having extreme problems
Time Frame
from baseline to 6 months
Title
change in EQ-VAS
Description
visual analogue scale (VAS) of EQ-5D Questionnaire scaled from 0-100, corresponding to the worse and the best health imagined
Time Frame
from baseline to 6 months
Secondary Outcome Measure Information:
Title
change in disease specific quality of life
Description
assessment of disease-related QoL using Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 7 heart failure domains. Scores of each domain are scaled from 0-100, with 0 corresponding to the worst, 100 the best status.
Time Frame
from baseline to 6 months
Title
change in heart rate variability
Description
assessed by Holter monitoring
Time Frame
from baseline to 6 months
Title
change in left ventricular end-systolic diameters (in millimeters)
Description
assessed by echocardiographic examination
Time Frame
from baseline to 6 months
Title
change in left ventricular end-diastolic diameters (in millimeters)
Description
assessed by echocardiographic examination
Time Frame
from baseline to 6 months
Title
change in left ventricular ejection fraction (in percentage)
Description
assessed by echocardiographic examination
Time Frame
from baseline to 6 months
Title
change in exercise tolerance
Description
assessed by the distance (in meters) walked on 6-minute walk test
Time Frame
from baseline to 6 months
Title
change in metabolic equivalents (METs)
Description
measured as (volume of O2 (ml) consumption/kg/min) / (3.5 ml VO2/kg/min)
Time Frame
from baseline to 6 months
Title
change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (in pg/ml)
Description
assessed by blood tests
Time Frame
from baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients newly diagnosed with heart failure or have been diagnosed with chronic heart failure
patients classified as NYHA II-IV (New York Heart Association)
Exclusion Criteria:
with severe liver or renal dysfunction
with severe systematic conditions such as infection, malignant hypertension etc.
hemodynamic instability (arrhythmia, acute cardiac infarction, aortic dissection etc.)
not cooperating due to psychomotor deficiency, or with contraindications for exercise testing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
haoren wang, M.D., M.S.
Phone
08641162893507
Email
haoren_wang@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
qin yu, M.D., Ph.D.
Organizational Affiliation
The Affiliated Zhongshan Hospital of Dalian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qin yu, M.D., Ph.D.
Phone
08641162887018
Email
yuqin@dlu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
age, gender, NYHA classification
Learn more about this trial
the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure
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