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

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ClinicalTrials.gov Identifier: NCT01340326
Recruitment Status : Completed
First Posted : April 22, 2011
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Kyungil Park, Dong-A University

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: high dose of valsartan Drug: usual dose of valsartan Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : November 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Valsartan

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

Valsartan, usual dose
usual dose group (valsartan 80 mg/day)
Drug: usual dose of valsartan
comparison of different dosages of drug




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340326


Locations
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Korea, Republic of
Department of Internal Medicine,Dong-A University College of Medicine
Busan, Korea, Republic of
Sponsors and Collaborators
Dong-A University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kyungil Park, Assistant professor, Dong-A University
ClinicalTrials.gov Identifier: NCT01340326    
Other Study ID Numbers: Donga 419
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Kyungil Park, Dong-A University:
Post myocardial infarction ventricular remodeling
valsartan
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action