Myocardial InfarctionPhase 4VALIDNCT01340326
The Impact of Dose of Angiotensin-receptor Blocker Valsartan and Genetic Polymorphism on the Post-MI Ventricular Remodeling
A Phase 4 study testing high dose of valsartan and usual dose of valsartan in people with Myocardial Infarction, run by Dong-A University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- high dose of valsartan and usual dose of valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine,Dong-A University College of Medicine
Busan
About this study
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- high dose of valsartan, usual dose of valsartan
- Keywords
- Post myocardial infarction ventricular remodeling, valsartan
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose of valsartanDrug
comparison of different dosages of drug
usual dose of valsartanDrug
comparison of different dosages of drug
| Study group | Role | What they receive |
|---|---|---|
| Valsartan,high dose | Active comparator | high dose group (valsartan up to 320 mg/day) Receives: Drug: high dose of valsartan |
| Valsartan, usual dose | Other | usual dose group (valsartan 80 mg/day) Receives: Drug: usual dose of valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the left ventricular volume index from baseline to follow-up
We measured a left ventriular volume index by echocardiography.
Measured: at 24hrs, 1month, and 12months after myocardial infarction
left ventricular volume index
Measured: at 12months after myocardial infarction
Secondary outcomes (2)
clinical events
Clinical events were defined as all cause death and hospitalization due to cardiovascular problems.
Measured: during 12 months follow up
clinical events
Measured: at 12 months after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startNov 2007
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyungil Park, Dong-A University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340326
- Sponsor's protocol ID
- Donga 419
- Acronym
- VALID
- Status last verified
- Nov 2015
- First submitted
- 20 Apr 2011
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22108275
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dose of Angiotensin-receptor Blocker Valsartan and Genetic Polymorphism on the Post-MI Ventricular Remodeling
- ClinicalTrials.gov ID
- NCT01340326
- Acronym / sponsor ID
- VALID / Donga 419
- Conditions
- Myocardial Infarction
- Keywords
- Post myocardial infarction ventricular remodeling, valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan,high dose | Active comparator | Drug: high dose of valsartanhigh dose group (valsartan up to 320 mg/day) |
| Valsartan, usual dose | Other | Drug: usual dose of valsartanusual dose group (valsartan 80 mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high dose of valsartancomparison of different dosages of drug | Drug | Valsartan,high dose |
| usual dose of valsartancomparison of different dosages of drug | Drug | Valsartan, usual dose |
Primary outcome
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.
left ventricular volume index
Time frame: at 12months after myocardial infarction
2 secondary outcomes
clinical events
Time frame: during 12 months follow up
clinical events
Time frame: at 12 months after myocardial infarction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 22108275Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing high dose of valsartan and usual dose of valsartan in people with Myocardial Infarction, run by Dong-A University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the left ventricular volume index from baseline to follow-up (time frame: at 24hrs, 1month, and 12months after myocardial infarction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01340326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.