Carvedilol Vascular Efficacy Trial (CARVEDIA)
| Tracking Information | |||||
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| First Received Date ICMJE | November 23, 2011 | ||||
| Last Updated Date | August 30, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Left Ventricular Ejection Fraction LVEF(%) [ Time Frame: 0 (baseline), 48 weeks (12 months) ] [ Designated as safety issue: Yes ] Change from baseline in Left Ventricular Ejection Fraction LVEF(%) at 12 months. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01484327 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Carvedilol Vascular Efficacy Trial | ||||
| Official Title ICMJE | Multicentre, Open-label, Non-interventional Observational Clinical Study Lasting 48 Weeks in Patients With Heart Failure or Reduced Left Ventricular Ejection Fraction Following Acute Myocardial Infarction Who Are Treated With Carvedilol | ||||
| Brief Summary | Beta-blockers should be administered to all patients with heart failure stages II to IV NYHA. It should also be administered to patients with stage I after myocardial infarction. The low ejection fraction, especially after myocardial infarction is a strong indication for beta-blockers, as many studies indicate that administration of these drugs substantially reduces cardiovascular mortality. Beta-blockers reduce mortality and hospitalizations and improve the operational phase for all categories of patients with heart failure. Since beta-blockers, only carvedilol, metoprolol, and recently visoprololi nevimpololi have shown these benefits and thus, only those have to be administered. The clinical study Carvedia aims to observe and record the action of beta-blocker carvedilol on cardiac function in patients with heart failure or reduced left ventricular ejection fraction after acute myocardial infarction. |
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| Detailed Description | The relationship between stroke volume, which is extruded from the left ventricle gives a measure for the restrictive left ventricular function. Any patient with known cardiovascular disease should undergo assessment of left ventricular function by measuring the ejection fraction. Several studies have shown that when the ejection fraction (LVEF), which measures the heart's ability to eject blood to the aorta does not exceed 40% (natural price ^ 50%) increased dramatically in the post-infarction mortality. The ejection fraction as a reliable predictor, can be measured by ultrasonography. The reduced ejection fraction is associated with an increased risk of life-threatening arrhythmias, heart failure and death. The low ejection fraction, especially after myocardial infarction is a strong indication for beta-blockers, as many studies indicate that administration of these drugs substantially reduces cardiovascular mortality. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with Heart Failure and post-MI LVEF<40% |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Carvedilol
Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg
Other Name: Carvepen |
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| Study Group/Cohort (s) | Carvedilol, LVEF, Heart Failure
Patients with Heart Failure on carvedilol therapy measured for their LVEF value
Intervention: Drug: Carvedilol |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 415 | ||||
| Completion Date | November 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Greece | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01484327 | ||||
| Other Study ID Numbers ICMJE | 2008-CAR-EL-02, Carvedia - 02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Elpen Pharmaceutical Co. Inc. | ||||
| Study Sponsor ICMJE | Elpen Pharmaceutical Co. Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Elpen Pharmaceutical Co. Inc. | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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