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

National Center for Cardiovascular Diseases

Status and phase: Unknown; Phase 4

Conditions: Diastolic Dysfunction; Coronary Heart Disease

Treatments: Drug: Trimetazidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03887013

CRFH20180050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 estimated patients

Sex: All

Ages: 50 to 79 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

226 participants in 2 patient groups

CHD routine therapy

No Intervention group

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.

CHD routine therapy+Trimetazidine

Experimental group

Description:

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

Treatment:

Drug: Trimetazidine