A Phase 4 interventional study of Trimetazidine in Coronary Heart Disease and Diastolic Dysfunction, sponsored by China National Center for Cardiovascular Diseases. Status unknown at 1 site in China. Open to participants aged 50 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-03-25.
Sponsored by China National Center for Cardiovascular Diseases · Phase 4, Interventional, and Treatment
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 226 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Trimetazidine
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).
Also known as: Cardiac metabolic modulator
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
Time frame: Within 6 months after patients being enrolled
Average E/e' ratio change between week 24 and baseline
Average e/e' is evaluated by ultracardiography
Time frame: Within 6 months after patients being enrolled
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
Time frame: Within 6 months after patients being enrolled
Velocity of tricuspid regurgitation change in m/s between week 24 and baseline
Velocity of tricuspid regurgitation is evaluated by ultracardiography
Time frame: Within 6 months after patients being enrolled
Index of left atrium volume change between week 24 and baseline
Index of left atrium volume is evaluated by ultracardiography
Time frame: Within 6 months after patients being enrolled
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
Time frame: Within 6 months after patients being enrolled
Number of participants with cardiovascular death and being rehospitalized for heart failure within 24 weeks treatment
This number will be acquired during follow up
Time frame: Within 6 months after patients being enrolled
Concentration of glycated hemoglobin (HbA1c) change in patients with diabetes mellitus (DM) between week 24 and baseline
HbA1c (%)is tested by Fuwai Hospital laboratory
Time frame: Within 6 months after patients being enrolled
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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China National Center for Cardiovascular Diseases