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Completed

NCT Number: NCT01484327

Carvedilol Vascular Efficacy Trial

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.

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Key information

Conditions

Heart Failure Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology University Clinic

Alexandroupoli, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients visiting outpatient clinics.
  • Male or female patients over 18 years
  • Patients with mild heart failure and history of symptoms according to the instructions of the European Society of Cardiology (ESC)
  • Patients who entered the study have LVEF <40% in echocardiography
  • Patients with new diagnosis of heart failure
  • Patients who have left ventricular ejection fraction after acute myocardial infarction <40%
  • Patients who have been treated in hospital during the previous month before their inclusion in the study
  • Patients who have signed the consent form for recording and processing of personal data.
  • Patients who are willing to comply with the requirements of the study
  • Patients who are treated with carvedilol for at least a month before their inclusion in this

Exclusion criteria

  • Patients under 18 years
  • Patients with unstable chronic heart failure
  • Patients with unstable hemodynamic profiles
  • Patients with heart valve disease
  • Patients with hypertrophic cardiomyopathy
  • Patients with unstable angina or active myocarditis
  • Patients with contraindications to treatment with beta-adrenergic receptors
  • Patients who have not consented to recording and processing of personal the data.
  • Women pregnant or breastfeeding
  • Patients have been treated in hospital during the preceding months before their inclusion in the study
  • Patients treated with carvedilol for less than one month

Treatment and study plan

Carvedilol

Drug

Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg

Other names: Carvepen

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction LVEF(%)

    Time frame: 0 (baseline), 48 weeks (12 months)

    Change from baseline in Left Ventricular Ejection Fraction LVEF(%) at 12 months.

Secondary outcomes

  1. Number of study participants with Adverse Events

    Time frame: 0 (baseline), 24 weeks (6 months), 48 weeks (12 months)

    Safety of carvedilol administration (reported AEs) from baseline until 12 months of treatment.

  2. Cardedilol dosage range

    Time frame: 0 (baseline), 24 weeks (6 months), 48 weeks

    Relation between carvedilol dose titration and change in LVEF

Sponsors and collaborators

Lead sponsor

Elpen Pharmaceutical Co. Inc.

Industry

Registry information

Official study 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

Acronym: CARVEDIA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2011
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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