Heart FailureCARVEDIANCT01484327
Carvedilol Vascular Efficacy Trial
An observational study of Heart Failure and Acute Myocardial Infarction, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Acute Myocardial Infarction
- What is being tested?
- Carvedilol
- How many people
- 415 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2009to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Heart Failure and post-MI LVEF<40%
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Carvedilol
- Keywords
- Heart Failure, Acute Myocardial Infarction, LVEF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called Carvepen
Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol, LVEF, Heart Failure | Patients with Heart Failure on carvedilol therapy measured for their LVEF value Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction LVEF(%)
Change from baseline in Left Ventricular Ejection Fraction LVEF(%) at 12 months.
Measured: 0 (baseline), 48 weeks (12 months)
Secondary outcomes (2)
Number of study participants with Adverse Events
Safety of carvedilol administration (reported AEs) from baseline until 12 months of treatment.
Measured: 0 (baseline), 24 weeks (6 months), 48 weeks (12 months)
Cardedilol dosage range
Relation between carvedilol dose titration and change in LVEF
Measured: 0 (baseline), 24 weeks (6 months), 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJan 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dimitrios Tziakas, A Professor, Principal investigator, University General Hospital of Alexandroupolis, Cardiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484327
- Sponsor's protocol ID
- 2008-CAR-EL-02
- Other IDs
- Carvedia - 02
- Acronym
- CARVEDIA
- Status last verified
- Nov 2011
- First submitted
- 23 Nov 2011
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01484327
- Acronym / sponsor ID
- CARVEDIA / 2008-CAR-EL-02
- Conditions
- Heart Failure, Acute Myocardial Infarction
- Keywords
- Heart Failure, Acute Myocardial Infarction, LVEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carvedilol, LVEF, Heart Failure | – | Drug: CarvedilolPatients with Heart Failure on carvedilol therapy measured for their LVEF value |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Heart Failure and post-MI LVEF<40%
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- Patients under 18 years
- Patients with unstable chronic heart failure
- Patients with unstable hemodynamic profiles
- Patients with heart valve disease
- Patients with hypertrophic cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolAlso: CarvepenMinimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg | Drug | Carvedilol, LVEF, Heart Failure |
Primary outcome
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.
2 secondary outcomes
Number of study participants with Adverse Events
Time frame: 0 (baseline), 24 weeks (6 months), 48 weeks (12 months)
Cardedilol dosage range
Time frame: 0 (baseline), 24 weeks (6 months), 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- 13th national congress for heart failure (Hellenic Society of Heart Failure)Link provided by the sponsor.
- European Society of Cardilogy - Heart Failure Congress 2012, Belgrade, Abstract No 60343Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Tziakas, A Professor principal investigator
University General Hospital of Alexandroupolis, Cardiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Acute Myocardial Infarction, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction LVEF(%) (time frame: 0 (baseline), 48 weeks (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.