Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Carvedia - 02 | Other Identifier | Elpen Pharmaceutical Co Inc |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol, LVEF, Heart Failure | Patients with Heart Failure on carvedilol therapy measured for their LVEF value |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Ejection Fraction LVEF(%) | Change from baseline in Left Ventricular Ejection Fraction LVEF(%) at 12 months. | 0 (baseline), 48 weeks (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of study participants with Adverse Events | Safety of carvedilol administration (reported AEs) from baseline until 12 months of treatment. | 0 (baseline), 24 weeks (6 months), 48 weeks (12 months) |
| Cardedilol dosage range |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with Heart Failure and post-MI LVEF<40%
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitrios Tziakas, A Professor | University General Hospital of Alexandroupolis, Cardiology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology University Clinic | Alexandroupoli | Greece |
Not provided
| Label | URL |
|---|---|
| 13th national congress for heart failure (Hellenic Society of Heart Failure) | View source |
| European Society of Cardilogy - Heart Failure Congress 2012, Belgrade, Abstract No 60343 | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Relation between carvedilol dose titration and change in LVEF
| 0 (baseline), 24 weeks (6 months), 48 weeks |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |