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Carvedilol vs. flecainida clinical trial in idiopathic ventricular arrhythmias.
EU CTIS ID: 2023-510362-26-00
What this study is testing
Compare between both treatments the average value of the ratio formed by dividing the number of ventricular latives measured in the 24-h Holter-ECG performed before starting the treatment divided by the number of ventricular latives measured in the 24-h Holter-ECG performed after to complete the treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of legal age capable of consenting.
You likely can't join if
- Allergy or adverse effects after previously taking flecainide and/or carvedilol.
- Significant heart failure secondary to tachemocardiopathy.
- History of structural heart disease, including: ischemic heart disease, moderate or severe valvular disease, moderate or severe left ventricular hypertrophy, cardiac surgery, sarcoidosis, congenital heart disease (including Brugada syndrome, long QT syndrome, short QT syndrome, cardiomyopathy and other less common conditions).
- Sinus dysfunction in patients who do not have pacemakers.
- Presence of accessory roads.
- Pregnancy and breastfeeding, since carvedilol is a drug that has been little studied in this context, which should be avoided if other alternatives are available.
See the full eligibility criteria
- Patients of legal age capable of consenting.
- Allergy or adverse effects after previously taking flecainide and/or carvedilol.
- Significant heart failure secondary to tachemocardiopathy.
- History of structural heart disease, including: ischemic heart disease, moderate or severe valvular disease, moderate or severe left ventricular hypertrophy, cardiac surgery, sarcoidosis, congenital heart disease (including Brugada syndrome, long QT syndrome, short QT syndrome, cardiomyopathy and other less common conditions).
- Sinus dysfunction in patients who do not have pacemakers.
- Presence of accessory roads.
- Pregnancy and breastfeeding, since carvedilol is a drug that has been little studied in this context, which should be avoided if other alternatives are available.
- Having received electrophysiological procedures will only be an exclusion criterion if it was performed to ablate malignant ventricular arrhythmias.
- Previous intake of flecainide and/or beta-blockers at therapeutic doses with the same indication as in the study. Patients in whom low doses are started and referred without adequate titration will not be excluded.
- Little arrhythmic load in Holter-electrocardiogram (Holter-ECG) that does not explain the patient's symptoms. Patients with less than 1000 ventricular beats on the 24-h Holter-ECG will not be accepted.
- Liver failure.
- Chronic kidney disease with glomerular filtration rate <30 ml/m2/min.
- Second or third degree atrioventricular block.
- First degree atrioventricular block with PR >220 ms.
- Duration of the QRS complex >120 ms.
- Moderately or severely depressed left ventricular ejection fraction (<40%).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.