Carvedilol Vascular Efficacy Trial (CARVEDIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01484327
First received: November 23, 2011
Last updated: August 30, 2012
Last verified: November 2011

November 23, 2011
August 30, 2012
January 2009
November 2011   (final data collection date for primary outcome measure)
Change in Left Ventricular Ejection Fraction LVEF(%) [ Time Frame: 0 (baseline), 48 weeks (12 months) ] [ Designated as safety issue: Yes ]
Change from baseline in Left Ventricular Ejection Fraction LVEF(%) at 12 months.
Same as current
Complete list of historical versions of study NCT01484327 on ClinicalTrials.gov Archive Site
  • Number of study participants with Adverse Events [ Time Frame: 0 (baseline), 24 weeks (6 months), 48 weeks (12 months) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Relation between carvedilol dose titration and change in LVEF
Same as current
Not Provided
Not Provided
 
Carvedilol Vascular Efficacy Trial
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

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with Heart Failure and post-MI LVEF<40%

  • Heart Failure
  • Acute Myocardial Infarction
Drug: Carvedilol
Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg
Other Name: Carvepen
Carvedilol, LVEF, Heart Failure
Patients with Heart Failure on carvedilol therapy measured for their LVEF value
Intervention: Drug: Carvedilol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
415
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01484327
2008-CAR-EL-02, Carvedia - 02
No
Elpen Pharmaceutical Co. Inc.
Elpen Pharmaceutical Co. Inc.
Not Provided
Principal Investigator: Dimitrios Tziakas, A Professor University General Hospital of Alexandroupolis, Cardiology Department
Elpen Pharmaceutical Co. Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP