Carvedilol Vascular Efficacy Trial (CARVEDIA)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||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|
- 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.
- Number of study participants with Adverse Events [ Time Frame: 0 (baseline), 24 weeks (6 months), 48 weeks (12 months) ] [ Designated as safety issue: Yes ]Safety of carvedilol administration (reported AEs) from baseline until 12 months of treatment.
- Cardedilol dosage range [ Time Frame: 0 (baseline), 24 weeks (6 months), 48 weeks ] [ Designated as safety issue: Yes ]Relation between carvedilol dose titration and change in LVEF
|Study Start Date:||January 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Carvedilol, LVEF, Heart Failure
Patients with Heart Failure on carvedilol therapy measured for their LVEF value
Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg
Other Name: Carvepen
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.
|Cardiology University Clinic|
|Principal Investigator:||Dimitrios Tziakas, A Professor||University General Hospital of Alexandroupolis, Cardiology Department|