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
  Purpose

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.


Condition Intervention
Heart Failure
Acute Myocardial Infarction
Drug: Carvedilol

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Elpen Pharmaceutical Co. Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 415
Study Start Date: January 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Carvedilol, LVEF, Heart Failure
Patients with Heart Failure on carvedilol therapy measured for their LVEF value
Drug: Carvedilol
Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg
Other Name: Carvepen

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484327

Locations
Greece
Cardiology University Clinic
Alexandroupolis, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
Principal Investigator: Dimitrios Tziakas, A Professor University General Hospital of Alexandroupolis, Cardiology Department
  More Information

Additional Information:
No publications provided

Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01484327     History of Changes
Other Study ID Numbers: 2008-CAR-EL-02, Carvedia - 02
Study First Received: November 23, 2011
Last Updated: August 30, 2012
Health Authority: Greece: National Organization of Medicines

Keywords provided by Elpen Pharmaceutical Co. Inc.:
Heart Failure
Acute Myocardial Infarction
LVEF

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Carvedilol
Adrenergic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014