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The Impact of Dose of Angiotensin-receptor Blocker Valsartan and Genetic Polymorphism on the Post-MI Ventricular Remodeling

NCT ID: NCT01340326

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Valsartan,high dose

high dose group (valsartan up to 320 mg/day)

Group Type ACTIVE_COMPARATOR

high dose of valsartan

Intervention Type DRUG

comparison of different dosages of drug

Valsartan, usual dose

usual dose group (valsartan 80 mg/day)

Group Type OTHER

usual dose of valsartan

Intervention Type DRUG

comparison of different dosages of drug

Interventions

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high dose of valsartan

comparison of different dosages of drug

Intervention Type DRUG

usual dose of valsartan

comparison of different dosages of drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Both gender
* Age \> 18
* First episode of acute ST-elevation MI
* An echocardiographic left ventricular ejection fraction less than 50 %
* Patients who provide written informed consent

Exclusion Criteria

* Contraindications for use of angiotensin receptor blockers (ARBs)(hypersensitivity, pregnancy, bilateral renal artery stenosis)
* Urgent need for revascularization procedure
* Severe heart failure (need for intravenous inotropic support)
* Persistent (\> 1 hour) severe hypotension (systolic blood pressure \< 90 mmHg)
* Refractory or potentially lethal arrhythmias
* Hemodynamically significant right ventricular infarction
* Primary valvular diseases
* Congenital heart disease
* Idiopathic hypertrophic cardiomyopathy
* Concomitant inflammatory cardiopathy
* Significant hepatic dysfunction
* Significant renal dysfunction
* Anemia (hemoglobin \< 10 mg/mL)
* Psychiatric disorders, alcohol or durg abuse
* Any concomitant disease that might interfere with drug evaluation (especially if life expectancy is less than 1 year)
* Participation in any other pharmacological study within 2 months
* Refusal or inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A University

OTHER

Sponsor Role lead

Responsible Party

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Kyungil Park

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Internal Medicine,Dong-A University College of Medicine

Busan, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 22108275 (View on PubMed)

Other Identifiers

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Donga 419

Identifier Type: -

Identifier Source: org_study_id