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

Phase 1

• Conditions: Chronic Heart Failure
• Interventions: Drug: Trimetazidine pills; Drug: YanXinShi pills; Drug: YanXinShi placebo pills; Drug: YanXinShi and Trimetazidine pills

• Registration Number: NCT03333499
• Lead Sponsor: Dalian University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-20
• Status Verified: 2017-11
• Study Start: 2017-11-01
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-07
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Trimetazidine group	Trimetazidine pills	Trimetazidine pills
YanXinShi group	YanXinShi pills	YanXinShi pills
the control group	YanXinShi placebo pills	YanXinShi placebo pills
YangXinShi and Trimetazidine group	YanXinShi and Trimetazidine pills	YanXinShi and Trimetazidine pills

Primary Outcome Measures

Name	Time	Method
change in EQ-5D Questionnaire	from baseline to 6 months	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	from baseline to 6 months	visual analogue scale (VAS) of EQ-5D Questionnaire scaled from 0-100, corresponding to the worse and the best health imagined

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University; 🇨🇳 Dalian, Liaoning, China