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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A University
• Treatments: Angiotensin Receptor Antagonists; Valsartan

Criteria

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