NCT03333499

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

October 20, 2017

Last Update Submit

November 26, 2017

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • change in disease specific quality of life

    from baseline to 6 months

  • change in heart rate variability

    from baseline to 6 months

  • change in left ventricular end-systolic diameters (in millimeters)

    from baseline to 6 months

  • change in left ventricular end-diastolic diameters (in millimeters)

    from baseline to 6 months

  • change in left ventricular ejection fraction (in percentage)

    from baseline to 6 months

  • +3 more secondary outcomes

Study Arms (4)

the control group

PLACEBO COMPARATOR

YanXinShi placebo pills

Drug: YanXinShi placebo pills

YanXinShi group

EXPERIMENTAL

YanXinShi pills

Drug: YanXinShi pills

Trimetazidine group

ACTIVE COMPARATOR

Trimetazidine pills

Drug: Trimetazidine pills

YangXinShi and Trimetazidine group

OTHER

YanXinShi and Trimetazidine pills

Drug: YanXinShi and Trimetazidine pills

Interventions

YanXinShi placebo pillsDRUG

participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure

the control group
YanXinShi pillsDRUG

participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure

YanXinShi group
Trimetazidine pillsDRUG

participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure

Trimetazidine group
YanXinShi and Trimetazidine pillsDRUG

participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure

YangXinShi and Trimetazidine group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients newly diagnosed with heart failure or have been diagnosed with chronic heart failure
  • patients classified as NYHA II-IV (New York Heart Association)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University

Dalian, Liaoning, 116001, China

RECRUITING

Study Officials

  • qin yu, M.D., Ph.D.

    Affiliated Zhongshan Hospital of Dalian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

haoren wang, M.D., M.S.

CONTACT

08641162893507haoren_wang@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

November 7, 2017

Study Start

November 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 28, 2017

Record last verified: 2017-11

Locations

CN(1)