An observational study in Heart Failure and Acute Myocardial Infarction, sponsored by Elpen Pharmaceutical Co. Inc.. Completed at 1 site in Greece. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Elpen Pharmaceutical Co. Inc. · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 415 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Elpen Pharmaceutical Co. Inc. is the lead sponsor of 43 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Heart Failure and post-MI LVEF\<40%
Exclusion Criteria:
Patients with Heart Failure on carvedilol therapy measured for their LVEF value
Drug: Carvedilol
Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg
Also known as: Carvepen
Change in Left Ventricular Ejection Fraction LVEF(%)
Change from baseline in Left Ventricular Ejection Fraction LVEF(%) at 12 months.
Time frame: 0 (baseline), 48 weeks (12 months)
Number of study participants with Adverse Events
Safety of carvedilol administration (reported AEs) from baseline until 12 months of treatment.
Time frame: 0 (baseline), 24 weeks (6 months), 48 weeks (12 months)
Cardedilol dosage range
Relation between carvedilol dose titration and change in LVEF
Time frame: 0 (baseline), 24 weeks (6 months), 48 weeks
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Elpen Pharmaceutical Co. Inc.