Carvedilol Vascular Efficacy Trial (CARVEDIA)
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|ClinicalTrials.gov Identifier: NCT01484327|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : August 31, 2012
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.
|Condition or disease||Intervention/treatment|
|Heart Failure Acute Myocardial Infarction||Drug: Carvedilol|
|Study Type :||Observational|
|Actual Enrollment :||415 participants|
|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|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
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
- Change in Left Ventricular Ejection Fraction LVEF(%) [ Time Frame: 0 (baseline), 48 weeks (12 months) ]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) ]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 ]Relation between carvedilol dose titration and change in LVEF
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484327
|Cardiology University Clinic|
|Principal Investigator:||Dimitrios Tziakas, A Professor||University General Hospital of Alexandroupolis, Cardiology Department|