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Angiotensin-converting enzyme inhibitors and angiotensin-receptor blocker valsartan ameliorate ventricular remodeling after myocardial infarction (MI). Although the amount of those drugs used in previous clinical trials, therefore recommended in practical guidelines is maximum clinical dose, it has not been clearly demonstrated whether the recommended dose is more efficacious compared to lower dose commonly used in clinical practice. In addition, the impact of genetic polymorphism in neurohormonal system on the pharmacological effect has not been explored in the setting of post-MI remodeling.
Therefore, the investigators evaluate whether submaximal dose, which are lower than those in major pivotal trials but typically used in clinical practice, can offer similar benefit in post-MI ventricular remodeling.
A total of 1116 patients with left ventricular (LV) dysfunction following the first episode of acute ST-elevation MI are to be enrolled and randomized to maximal tolerable dose (up to 320 mg/day) or usual dose (80 mg/day) of valsartan for 12 months in 2:1 ratio. Echocardiographic analysis for quantifying post-MI ventricular remodeling and genotyping of blood samples are conducted in central core laboratory. Clinical assessment and laboratory test are performed at fixed times, and genetic polymorphisms of the patients are tested at the time of admission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan,high dose | Active Comparator | high dose group (valsartan up to 320 mg/day) |
|
| Valsartan, usual dose | Other | usual dose group (valsartan 80 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high dose of valsartan | Drug | comparison of different dosages of drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the left ventricular volume index from baseline to follow-up | We measured a left ventriular volume index by echocardiography. | at 24hrs, 1month, and 12months after myocardial infarction |
| left ventricular volume index | at 12months after myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| clinical events | Clinical events were defined as all cause death and hospitalization due to cardiovascular problems. | during 12 months follow up |
| clinical events | at 12 months after myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine,Dong-A University College of Medicine | Busan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22108275 | Derived | Cho YR, Kim YD, Park TH, Park K, Park JS, Baek H, Choi SY, Kim KS, Hong TJ, Yang TH, Hwang JY, Park JS, Hur SH, Lee SG. The impact of dose of the angiotensin-receptor blocker valsartan on the post-myocardial infarction ventricular remodeling: study protocol for a randomized controlled trial. Trials. 2011 Nov 22;12:247. doi: 10.1186/1745-6215-12-247. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| usual dose of valsartan |
| Drug |
comparison of different dosages of drug |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |