Back to resultsThe Impact of Dose of Angiotensin-receptor Blocker Valsartan and Genetic Polymorphism on the Post-MI Ventricular Remodeling (VALID)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
high dose of valsartan
usual dose of valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Post myocardial infarction ventricular remodeling, valsartan
Eligibility 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
Sites / Locations
- Department of Internal Medicine,Dong-A University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Valsartan,high dose
Valsartan, usual dose
Arm Description
high dose group (valsartan up to 320 mg/day)
usual dose group (valsartan 80 mg/day)
Outcomes
Primary Outcome Measures
Change in the left ventricular volume index from baseline to follow-up
We measured a left ventriular volume index by echocardiography.
left ventricular volume index
Secondary Outcome Measures
clinical events
Clinical events were defined as all cause death and hospitalization due to cardiovascular problems.
clinical events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01340326
Brief Title
The Impact of Dose of Angiotensin-receptor Blocker Valsartan and Genetic Polymorphism on the Post-MI Ventricular Remodeling
Acronym
VALID
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Post myocardial infarction ventricular remodeling, valsartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valsartan,high dose
Arm Type
Active Comparator
Arm Description
high dose group (valsartan up to 320 mg/day)
Arm Title
Valsartan, usual dose
Arm Type
Other
Arm Description
usual dose group (valsartan 80 mg/day)
Intervention Type
Drug
Intervention Name(s)
high dose of valsartan
Intervention Description
comparison of different dosages of drug
Intervention Type
Drug
Intervention Name(s)
usual dose of valsartan
Intervention Description
comparison of different dosages of drug
Primary Outcome Measure Information:
Title
Change in the left ventricular volume index from baseline to follow-up
Description
We measured a left ventriular volume index by echocardiography.
Time Frame
at 24hrs, 1month, and 12months after myocardial infarction
Title
left ventricular volume index
Time Frame
at 12months after myocardial infarction
Secondary Outcome Measure Information:
Title
clinical events
Description
Clinical events were defined as all cause death and hospitalization due to cardiovascular problems.
Time Frame
during 12 months follow up
Title
clinical events
Time Frame
at 12 months after myocardial infarction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Internal Medicine,Dong-A University College of Medicine
City
Busan
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22108275
Citation
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.
Results Reference
derived
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The Impact of Dose of Angiotensin-receptor Blocker Valsartan and Genetic Polymorphism on the Post-MI Ventricular Remodeling
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