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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Drug: YanXinShi placebo pills; Drug: YanXinShi pills; Drug: Trimetazidine pills; Drug: YanXinShi and Trimetazidine pills

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116001
      • Recruiting
      • Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University
      • Contact: qin yu, M.D., Ph.D.; Phone Number: 08641162887018; Email: yuqin@dlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: the control group; YanXinShi placebo pills	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
Experimental: YanXinShi group; YanXinShi pills	Drug: YanXinShi pills; participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure
Active Comparator: Trimetazidine group; Trimetazidine pills	Drug: Trimetazidine pills; participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
Other: YangXinShi and Trimetazidine group; YanXinShi and Trimetazidine pills	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in exercise tolerance	assessed by the distance (in meters) walked on 6-minute walk test	from baseline to 6 months
change in left ventricular ejection fraction (in percentage)	assessed by echocardiographic examination	from baseline to 6 months
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
change in heart rate variability	assessed by Holter monitoring	from baseline to 6 months
change in left ventricular end-systolic diameters (in millimeters)	assessed by echocardiographic examination	from baseline to 6 months
change in left ventricular end-diastolic diameters (in millimeters)	assessed by echocardiographic examination	from baseline to 6 months
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
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

Collaborators and Investigators

• Sponsor: Dalian University
• Investigators: Principal Investigator: qin yu, M.D., Ph.D., the Affiliated Zhongshan Hospital of Dalian University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 26, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Vasodilator Agents; Trimetazidine
• Other Study ID Numbers: zsyy_xhs2017-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: age, gender, NYHA classification

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No