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Completed

NCT Number: NCT01340326

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Busan, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high dose of valsartan

Drug

comparison of different dosages of drug

usual dose of valsartan

Drug

comparison of different dosages of drug

Primary outcomes

  1. 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.

  2. left ventricular volume index

    Time frame: at 12months after myocardial infarction

Secondary outcomes

  1. clinical events

    Time frame: during 12 months follow up

    Clinical events were defined as all cause death and hospitalization due to cardiovascular problems.

  2. clinical events

    Time frame: at 12 months after myocardial infarction

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Registry information

Acronym: VALID

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2011
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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