Carvedilol Vascular Efficacy Trial

Heart Failure Clinical Trial

— CARVEDIA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484327
• Other study ID #: 2008-CAR-EL-02
• Secondary ID: Carvedia - 02
• Status: Completed
• Start date: January 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients visiting outpatient clinics.

2. Male or female patients over 18 years

3. Patients with mild heart failure and history of symptoms according to the instructions of the European Society of Cardiology (ESC)

4. Patients who entered the study have LVEF <40% in echocardiography

5. Patients with new diagnosis of heart failure

6. Patients who have left ventricular ejection fraction after acute myocardial infarction <40%

7. Patients who have been treated in hospital during the previous month before their inclusion in the study

8. Patients who have signed the consent form for recording and processing of personal data.

9. Patients who are willing to comply with the requirements of the study

10. Patients who are treated with carvedilol for at least a month before their inclusion in this

Exclusion Criteria:

1. Patients under 18 years

2. Patients with unstable chronic heart failure

3. Patients with unstable hemodynamic profiles

4. Patients with heart valve disease

5. Patients with hypertrophic cardiomyopathy

6. Patients with unstable angina or active myocarditis

7. Patients with contraindications to treatment with beta-adrenergic receptors

8. Patients who have not consented to recording and processing of personal the data.

9. Women pregnant or breastfeeding

10. Patients have been treated in hospital during the preceding months before their inclusion in the study

11. Patients treated with carvedilol for less than one month

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Carvedilol
Minimum dosage 3.125 mg ? 2, Maximum dosage 50 mg

Locations

Country	Name	City	State
Greece	Cardiology University Clinic	Alexandroupolis

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Cardedilol dosage range	Relation between carvedilol dose titration and change in LVEF	0 (baseline), 24 weeks (6 months), 48 weeks

External Links

•   13th national congress for heart failure (Hellenic Society of Heart Failure)
•   European Society of Cardilogy - Heart Failure Congress 2012, Belgrade, Abstract No 60343