Carvedilol Vascular Efficacy Trial

NCT ID: NCT01484327

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 415 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-11-30

Brief 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.

Detailed 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.

Conditions

Heart Failure; Acute Myocardial Infarction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Carvedilol, LVEF, Heart Failure

Patients with Heart Failure on carvedilol therapy measured for their LVEF value

Carvedilol

Intervention Type: DRUG

Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg

Interventions

Carvedilol

Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg

Intervention Type: DRUG

Other Intervention Names

Carvepen

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elpen Pharmaceutical Co. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitrios Tziakas, A Professor

Role: PRINCIPAL_INVESTIGATOR

University General Hospital of Alexandroupolis, Cardiology Department

Locations

Cardiology University Clinic

Alexandroupoli, , Greece

Countries

Greece

Related Links

http://heartfailuregreece.blogspot.com/2012/02/13.html

13th national congress for heart failure (Hellenic Society of Heart Failure)

http://escol.escardio.org/MyESC/modules/congress/Abstract/default.aspx?eventID=156

European Society of Cardilogy - Heart Failure Congress 2012, Belgrade, Abstract No 60343

Other Identifiers

Carvedia - 02

Identifier Type: OTHER

Identifier Source: secondary_id

2008-CAR-EL-02

Identifier Type: -

Identifier Source: org_study_id