the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03333499
• Other study ID #: zsyy_xhs2017-10
• Status: Recruiting
• Phase: Phase 1
• First received: October 20, 2017
• Last updated: November 26, 2017
• Start date: November 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: Dalian University
• Contact: haoren wang, M.D., M.S.
• Phone: 08641162893507
• Email: haoren_wang[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• YanXinShi placebo pills
participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure
• YanXinShi pills
participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure
• Trimetazidine pills
participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
• YanXinShi and Trimetazidine pills
participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure

Locations

Country	Name	City	State
China	Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Dalian University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from baseline to 6 months
Primary	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	from baseline to 6 months
Secondary	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.	from baseline to 6 months
Secondary	change in heart rate variability	assessed by Holter monitoring	from baseline to 6 months
Secondary	change in left ventricular end-systolic diameters (in millimeters)	assessed by echocardiographic examination	from baseline to 6 months
Secondary	change in left ventricular end-diastolic diameters (in millimeters)	assessed by echocardiographic examination	from baseline to 6 months
Secondary	change in left ventricular ejection fraction (in percentage)	assessed by echocardiographic examination	from baseline to 6 months
Secondary	change in exercise tolerance	assessed by the distance (in meters) walked on 6-minute walk test	from baseline to 6 months
Secondary	change in metabolic equivalents (METs)	measured as (volume of O2 (ml) consumption/kg/min) / (3.5 ml VO2/kg/min)	from baseline to 6 months
Secondary	change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (in pg/ml)	assessed by blood tests	from baseline to 6 months