Coronary Heart DiseasePhase 4NCT03887013
Cardiac Metabolic Modulator Treatment for Improvement of Diastolic Function in Patients With Coronary Heart Disease
A Phase 4 study testing Trimetazidine in people with Coronary Heart Disease and Diastolic Dysfunction, run by China National Center for Cardiovascular Diseases at 1 site in China.
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)… Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Coronary Heart Disease, Diastolic Dysfunction
- What is being tested?
- Trimetazidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2019to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Wenyao Wang, MD, 00861088396173, wwypumc@126.com
About this study
Official title: Cardiac Metabolic Modulator Treatment for Improvement of Left Ventricular Diastolic Function in Patients With Coronary Heart Disease: a Prospective, Randomized Controlled Study
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.
Read the 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
- Being tested
- Trimetazidine
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimetazidineDrug
Also called Cardiac metabolic modulator
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).
| Study group | Role | What they receive |
|---|---|---|
| CHD routine therapy | No intervention | 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 | Apart from the drug and PCI therapy mentioned above,patients will be given treatment of trimetazidine. Receives: Drug: Trimetazidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 6 months after patients being enrolled
Secondary outcomes (7)
Average E/e' ratio change between week 24 and baseline
Average e/e' is evaluated by ultracardiography
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 6 months after patients being enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start25 Mar 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yan Zhao, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887013
- Sponsor's protocol ID
- CRFH20180050
- Status last verified
- Oct 2018
- First submitted
- 19 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Metabolic Modulator Treatment for Improvement of Left Ventricular Diastolic Function in Patients With Coronary Heart Disease: a Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03887013
- Acronym / sponsor ID
- CRFH20180050
- Conditions
- Coronary Heart Disease, Diastolic Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 25 Mar 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHD routine therapy | No intervention | –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 | Drug: TrimetazidineApart from the drug and PCI therapy mentioned above,patients will be given treatment of trimetazidine. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrimetazidineAlso: Cardiac metabolic modulatorTrimetazidine 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). | Drug | CHD routine therapy+Trimetazidine |
Primary outcome
Percentage difference of patients with II or III degree diastolic dysfunction in each arm
Time frame: Within 6 months after patients being enrolled
II or III degree diastolic dysfunction is defined as average E/e' ratio more than 10
7 secondary outcomes
Average E/e' ratio change between week 24 and baseline
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
Time frame: Within 6 months after patients being enrolled
Velocity of tricuspid regurgitation change in m/s between week 24 and baseline
Time frame: Within 6 months after patients being enrolled
Index of left atrium volume change between week 24 and baseline
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
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
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
Time frame: Within 6 months after patients being enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Zhao principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trimetazidine in people with Coronary Heart Disease and Diastolic Dysfunction, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhao (008615810783328, zhaoyanfuwai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage difference of patients with II or III degree diastolic dysfunction in each arm (time frame: Within 6 months after patients being enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.