NCT01340326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

7.1 years

First QC Date

April 20, 2011

Last Update Submit

November 30, 2015

Conditions

Myocardial Infarction

Keywords

Post myocardial infarction ventricular remodelingvalsartan

Outcome Measures

Primary Outcomes (2)

  • 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

  • left ventricular volume index

    at 12months after myocardial infarction

Secondary Outcomes (2)

  • clinical events

    during 12 months follow up

  • clinical events

    at 12 months after myocardial infarction

Study Arms (2)

Valsartan,high dose

ACTIVE COMPARATOR

high dose group (valsartan up to 320 mg/day)

Drug: high dose of valsartan

Valsartan, usual dose

OTHER

usual dose group (valsartan 80 mg/day)

Drug: usual dose of valsartan

Interventions

high dose of valsartanDRUG

comparison of different dosages of drug

Valsartan,high dose
usual dose of valsartanDRUG

comparison of different dosages of drug

Valsartan, usual dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Busan, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 22108275DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 22, 2011

Study Start

November 1, 2007

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

KR(1)