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

Myocardial Infarction Clinical Trial

— VALID  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340326
• Other study ID #: Donga 419
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2011
• Last updated: November 30, 2015
• Start date: November 2007
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Ventricular Remodeling

Intervention

Drug:
• high dose of valsartan
comparison of different dosages of drug
• usual dose of valsartan
comparison of different dosages of drug

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine,Dong-A University College of Medicine	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	left ventricular volume index		at 12months after myocardial infarction	No
Secondary	clinical events	Clinical events were defined as all cause death and hospitalization due to cardiovascular problems.	during 12 months follow up	Yes
Secondary	clinical events		at 12 months after myocardial infarction	No