Coronary Heart Disease, Diastolic Dysfunction
Conditions
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.
Interventions
DRUGTrimetazidine
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).
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage difference of patients with II or III degree diastolic dysfunction in each arm | Within 6 months after patients being enrolled | II or III degree diastolic dysfunction is defined as average E/e' ratio more than 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average E/e' ratio change between week 24 and baseline | Within 6 months after patients being enrolled | 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 | Within 6 months after patients being enrolled | 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 | Within 6 months after patients being enrolled | Velocity of tricuspid regurgitation is evaluated by ultracardiography |
| Index of left atrium volume change between week 24 and baseline | Within 6 months after patients being enrolled | 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 | Within 6 months after patients being enrolled | NT-proBNP is tested by Fuwai Hospital laboratory |
| Number of participants with cardiovascular death and being rehospitalized for heart failure within 24 weeks treatment | Within 6 months after patients being enrolled | 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 | Within 6 months after patients being enrolled | HbA1c (%)is tested by Fuwai Hospital laboratory |
Countries
China
Contacts
Primary ContactYan Zhao
Backup ContactKuo Zhang
Outcome results
None listed