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

NCT ID: NCT03887013

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2020-12-31

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.

Conditions

Coronary Heart Disease; Diastolic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CHD routine therapy

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CHD routine therapy+Trimetazidine

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

Group Type: EXPERIMENTAL

Trimetazidine

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Cardiac metabolic modulator

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Zhao

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yan Zhao

Role: CONTACT

zhaoyanfuwai@163.com

008615810783328

Kuo Zhang

Role: CONTACT

kzhang23@126.com

008618813019602

Facility Contacts

Wenyao Wang, MD

Role: primary

wwypumc@126.com

00861088396173

Other Identifiers

CRFH20180050

Identifier Type: -

Identifier Source: org_study_id