Cardiac Metabolic Modulator Treatment for Improvement of Diastolic Function in Patients With Coronary Heart Disease
1 other identifier
interventional
226
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 22, 2019
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 25, 2019
October 1, 2018
1.5 years
March 19, 2019
March 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Average E/e' ratio change between week 24 and baseline
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
Within 6 months after patients being enrolled
Velocity of tricuspid regurgitation change in m/s between week 24 and baseline
Within 6 months after patients being enrolled
Index of left atrium volume change between week 24 and baseline
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
Within 6 months after patients being enrolled
- +2 more secondary outcomes
Study Arms (2)
CHD routine therapy
NO INTERVENTIONPatients 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
EXPERIMENTALApart from the drug and PCI therapy mentioned above,patients will be given treatment of trimetazidine.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Zhao
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2019
First Posted
March 22, 2019
Study Start
March 25, 2019
Primary Completion
October 1, 2020
Study Completion
December 1, 2020
Last Updated
March 25, 2019
Record last verified: 2018-10