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

November 30, 2015 updated by: Kyungil Park, Dong-A University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Department of Internal Medicine,Dong-A University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Valsartan,high dose
high dose group (valsartan up to 320 mg/day)
Drug: high dose of valsartan
comparison of different dosages of drug
Other: Valsartan, usual dose
usual dose group (valsartan 80 mg/day)
Drug: usual dose of valsartan
comparison of different dosages of drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the left ventricular volume index from baseline to follow-up
Time Frame: at 24hrs, 1month, and 12months after myocardial infarction
We measured a left ventriular volume index by echocardiography.
at 24hrs, 1month, and 12months after myocardial infarction
left ventricular volume index
Time Frame: at 12months after myocardial infarction
at 12months after myocardial infarction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical events
Time Frame: during 12 months follow up
Clinical events were defined as all cause death and hospitalization due to cardiovascular problems.
during 12 months follow up
clinical events
Time Frame: at 12 months after myocardial infarction
at 12 months after myocardial infarction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Donga 419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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