Clinical trial NCT01484327: Carvedilol Vascular Efficacy Trial
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Acute Myocardial Infarction
Keywords: Heart Failure
Acute Myocardial Infarction
LVEF
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Heart Failure and post-MI LVEF\<40%

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.

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

Primary outcomes:
measure: Change in Left Ventricular Ejection Fraction LVEF(%)
timeFrame: 0 (baseline), 48 weeks (12 months)
Secondary outcomes:
measure: Number of study participants with Adverse Events
timeFrame: 0 (baseline), 24 weeks (6 months), 48 weeks (12 months)
measure: Cardedilol dosage range
timeFrame: 0 (baseline), 24 weeks (6 months), 48 weeks
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Cardiology University Clinic
Study officials:
affiliation: University General Hospital of Alexandroupolis, Cardiology Department
name: Dimitrios Tziakas, A Professor
role: PRINCIPAL_INVESTIGATOR
References: