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

Coronary Heart Disease Clinical Trial

Official title:

Cardiac Metabolic Modulator Treatment for Improvement of Left Ventricular Diastolic Function in Patients With Coronary Heart Disease: a Prospective, Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03887013
• Other study ID #: CRFH20180050
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 25, 2019
• Est. completion date: December 2020

Study information

• Verified date: October 2018
• Source: China National Center for Cardiovascular Diseases
• Contact: Yan Zhao
• Phone: 008615810783328
• Email: zhaoyanfuwai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 226
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Diastolic Dysfunction
• Heart Diseases
• Myocardial Ischemia

Intervention

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).

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 6 months after patients being enrolled
Secondary	Average E/e' ratio change between week 24 and baseline	Average e/e' is evaluated by ultracardiography	Within 6 months after patients being enrolled
Secondary	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	Within 6 months after patients being enrolled
Secondary	Velocity of tricuspid regurgitation change in m/s between week 24 and baseline	Velocity of tricuspid regurgitation is evaluated by ultracardiography	Within 6 months after patients being enrolled
Secondary	Index of left atrium volume change between week 24 and baseline	Index of left atrium volume is evaluated by ultracardiography	Within 6 months after patients being enrolled
Secondary	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	Within 6 months after patients being enrolled
Secondary	Number of participants with cardiovascular death and being rehospitalized for heart failure within 24 weeks treatment	This number will be acquired during follow up	Within 6 months after patients being enrolled
Secondary	Concentration of glycated hemoglobin (HbA1c) change in patients with diabetes mellitus (DM) between week 24 and baseline	HbA1c (%)is tested by Fuwai Hospital laboratory	Within 6 months after patients being enrolled