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Cardiac Metabolic Modulator Treatment for Improvement of Diastolic Function in Patients With Coronary Heart Disease

Primary Purpose

Coronary Heart Disease, Diastolic Dysfunction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Trimetazidine
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged between 50 and 79 years,male or female (without pregnancy).
  • Diagnosed CHD by coronary angiography,with stenoses in main bifurcations less than 70% after PCI treatment.
  • Left ventricular ejection fraction(LVEF) more than 50% assessed by ultracardiography.
  • Characteristics of diastolic dysfunction by ultracardiography (more than 2 criteria as following):(1)Average E/e'>14,(2)Septal e' velocity <7 cm/s or lateral e' velocity <10 cm/s,(3)Tricuspid regurgitation (TR) velocity >2.8m/s,(4)Left atrium (LA) volume index >34ml/m2.
  • Not yet being treated by trimetazidine.
  • Provided informed consent.

Exclusion Criteria:

  • Acute heart failure or acute exacerbation of chronic heart failure.
  • LVEF less than 50% at admission or in the past.
  • History of malignant tumor or life expectancy under 12 months.
  • Acute myocardial infarction or unstable angina pectoris within 3 months.
  • Scheduled coronary artery bypass grafting therapy within 6 months.
  • Diagnosed or considered valvular heart disease, hypertrophic cardiomyopathy,restrictive cardiomyopathy or pericardium diseases.
  • Significant hepatic impairment (Serum glutamate-pyruvate transaminase more than 3 times normal upper limit) or severe renal dysfunction (eGFR≤30 ml/min/1.73m2).
  • Known or considered Parkinson's Disease.
  • Known hypersensitivity or intolerance to trimetazidine.
  • Pregnancy and lactation period.
  • Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol.
  • Participation in another clinical trial within the past 30 days.

Sites / Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

CHD routine therapy

CHD routine therapy+Trimetazidine

Arm Description

Patients with CHD will be treated with evidence-based therapy including antiplatelet drugs,beta-blockers,statins,angiotensin-converting enzyme inhibitor (ACEI),nitrates,etc. Percutaneous coronary intervention (PCI) could be performed if needed.

Apart from the drug and PCI therapy mentioned above,patients will be given treatment of trimetazidine.

Outcomes

Primary Outcome Measures

Percentage difference of patients with II or III degree diastolic dysfunction in each arm
II or III degree diastolic dysfunction is defined as average E/e' ratio more than 10

Secondary Outcome Measures

Average E/e' ratio change between week 24 and baseline
Average e/e' is evaluated by ultracardiography
E' velocity change of septum or of left ventricular lateral wall in m/s between week24 and baseline
E' velocity change of septum or of left ventricular lateral wall is evaluated by ultracardiography
Velocity of tricuspid regurgitation change in m/s between week 24 and baseline
Velocity of tricuspid regurgitation is evaluated by ultracardiography
Index of left atrium volume change between week 24 and baseline
Index of left atrium volume is evaluated by ultracardiography
Concentration of the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) change in pg/ml between week 24 and baseline
NT-proBNP is tested by Fuwai Hospital laboratory
Number of participants with cardiovascular death and being rehospitalized for heart failure within 24 weeks treatment
This number will be acquired during follow up
Concentration of glycated hemoglobin (HbA1c) change in patients with diabetes mellitus (DM) between week 24 and baseline
HbA1c (%)is tested by Fuwai Hospital laboratory

Full Information

First Posted
March 19, 2019
Last Updated
March 21, 2019
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT03887013
Brief Title
Cardiac Metabolic Modulator Treatment for Improvement of Diastolic Function in Patients With Coronary Heart Disease
Official Title
Cardiac Metabolic Modulator Treatment for Improvement of Left Ventricular Diastolic Function in Patients With Coronary Heart Disease: a Prospective, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2019 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Based on accumulating evidence showing that impaired cardiac energetic metabolism plays important role in the mechanism of cardiac diastolic dysfunction,the study is designed to evaluate whether metabolic modulator treatment with trimetazidine could have beneficial effects on patients with coronary heart disease(CHD) and ventricular diastolic dysfunction.This study is a prospective,randomised,open-label trial to assess the efficacy of trimetazidine treatment in improving diastolic function in CHD patients with diastolic dysfunction.
Detailed Description
The primary objective of this trial is to determine whether the 24-week trimetazidine therapy, as an adjunct to routine treatment for CHD, would improve diastolic function in patients with ischemic heart disease compared to the routine treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Diastolic Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHD routine therapy
Arm Type
No Intervention
Arm Description
Patients with CHD will be treated with evidence-based therapy including antiplatelet drugs,beta-blockers,statins,angiotensin-converting enzyme inhibitor (ACEI),nitrates,etc. Percutaneous coronary intervention (PCI) could be performed if needed.
Arm Title
CHD routine therapy+Trimetazidine
Arm Type
Experimental
Arm Description
Apart from the drug and PCI therapy mentioned above,patients will be given treatment of trimetazidine.
Intervention Type
Drug
Intervention Name(s)
Trimetazidine
Other Intervention Name(s)
Cardiac metabolic modulator
Intervention Description
Trimetazidine is given as 20mg every time and three times per day (Tid) or 20mg every time and two times per day (when renal function is declined).
Primary Outcome Measure Information:
Title
Percentage difference of patients with II or III degree diastolic dysfunction in each arm
Description
II or III degree diastolic dysfunction is defined as average E/e' ratio more than 10
Time Frame
Within 6 months after patients being enrolled
Secondary Outcome Measure Information:
Title
Average E/e' ratio change between week 24 and baseline
Description
Average e/e' is evaluated by ultracardiography
Time Frame
Within 6 months after patients being enrolled
Title
E' velocity change of septum or of left ventricular lateral wall in m/s between week24 and baseline
Description
E' velocity change of septum or of left ventricular lateral wall is evaluated by ultracardiography
Time Frame
Within 6 months after patients being enrolled
Title
Velocity of tricuspid regurgitation change in m/s between week 24 and baseline
Description
Velocity of tricuspid regurgitation is evaluated by ultracardiography
Time Frame
Within 6 months after patients being enrolled
Title
Index of left atrium volume change between week 24 and baseline
Description
Index of left atrium volume is evaluated by ultracardiography
Time Frame
Within 6 months after patients being enrolled
Title
Concentration of the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) change in pg/ml between week 24 and baseline
Description
NT-proBNP is tested by Fuwai Hospital laboratory
Time Frame
Within 6 months after patients being enrolled
Title
Number of participants with cardiovascular death and being rehospitalized for heart failure within 24 weeks treatment
Description
This number will be acquired during follow up
Time Frame
Within 6 months after patients being enrolled
Title
Concentration of glycated hemoglobin (HbA1c) change in patients with diabetes mellitus (DM) between week 24 and baseline
Description
HbA1c (%)is tested by Fuwai Hospital laboratory
Time Frame
Within 6 months after patients being enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged between 50 and 79 years,male or female (without pregnancy). Diagnosed CHD by coronary angiography,with stenoses in main bifurcations less than 70% after PCI treatment. Left ventricular ejection fraction(LVEF) more than 50% assessed by ultracardiography. Characteristics of diastolic dysfunction by ultracardiography (more than 2 criteria as following):(1)Average E/e'>14,(2)Septal e' velocity <7 cm/s or lateral e' velocity <10 cm/s,(3)Tricuspid regurgitation (TR) velocity >2.8m/s,(4)Left atrium (LA) volume index >34ml/m2. Not yet being treated by trimetazidine. Provided informed consent. Exclusion Criteria: Acute heart failure or acute exacerbation of chronic heart failure. LVEF less than 50% at admission or in the past. History of malignant tumor or life expectancy under 12 months. Acute myocardial infarction or unstable angina pectoris within 3 months. Scheduled coronary artery bypass grafting therapy within 6 months. Diagnosed or considered valvular heart disease, hypertrophic cardiomyopathy,restrictive cardiomyopathy or pericardium diseases. Significant hepatic impairment (Serum glutamate-pyruvate transaminase more than 3 times normal upper limit) or severe renal dysfunction (eGFR≤30 ml/min/1.73m2). Known or considered Parkinson's Disease. Known hypersensitivity or intolerance to trimetazidine. Pregnancy and lactation period. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol. Participation in another clinical trial within the past 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhao
Phone
008615810783328
Email
zhaoyanfuwai@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo Zhang
Phone
008618813019602
Email
kzhang23@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhao
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyao Wang, MD
Phone
00861088396173
Email
wwypumc@126.com

12. IPD Sharing Statement

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Cardiac Metabolic Modulator Treatment for Improvement of Diastolic Function in Patients With Coronary Heart Disease

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