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

Dalian University

Status and phase: Unknown; Phase 1

Conditions: Chronic Heart Failure

Treatments: Drug: Trimetazidine pills; Drug: YanXinShi and Trimetazidine pills; Drug: YanXinShi pills; Drug: YanXinShi placebo pills

Study type: Interventional

Funder types: Other

Identifiers

NCT03333499

zsyy_xhs2017-10

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

the control group

Placebo Comparator group

Description:

YanXinShi placebo pills

Treatment:

Drug: YanXinShi placebo pills

YanXinShi group

Experimental group

Description:

YanXinShi pills

Treatment:

Drug: YanXinShi pills

Trimetazidine group

Active Comparator group

Description:

Trimetazidine pills

Treatment:

Drug: Trimetazidine pills

YangXinShi and Trimetazidine group

Other group

Description:

YanXinShi and Trimetazidine pills

Treatment:

Drug: YanXinShi and Trimetazidine pills