CARVEDILOL for Idiopathic ventricular arrhythmias | Ventricular extrasystoles | Monomorphic ventricular tachycardia

Inclusion criteria

• {"criterion_text":"- Patients of legal age capable of consenting."}

Exclusion criteria

• {"criterion_text":"- Allergy or adverse effects after previously taking flecainide and/or carvedilol."}
• {"criterion_text":"- Significant heart failure secondary to tachemocardiopathy."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Sinus dysfunction in patients who do not have pacemakers."}
• {"criterion_text":"- Presence of accessory roads."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Having received electrophysiological procedures will only be an exclusion criterion if it was performed to ablate malignant ventricular arrhythmias."}
• {"criterion_text":"- Previous intake of flecainida 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Liver failure."}
• {"criterion_text":"- Chronic kidney disease with glomerular filtration rate <30 ml/m2/min."}
• {"criterion_text":"- Second or third degree atrioventricular block."}
• {"criterion_text":"- First degree atrioventricular block with PR >220 ms."}
• {"criterion_text":"- Duration of the QRS complex >120 ms."}
• {"criterion_text":"- Moderately or severely depressed left ventricular ejection fraction (<40%)."}

Primary endpoints

• {"endpoint_text":"- Difference between both groups in the average value of the ratio formed by dividing the number of ventricular beats measured in the 24-h Holter-ECG performed before starting treatment divided by the number of ventricular beats measured in the 24-h Holter-ECG performed after after completing treatment.","definition_or_measurement_approach":"Measured by 24-h Holter-ECG performed before starting treatment and after completing treatment; primary variable is the average value of the ratio (number of ventricular beats pre-treatment divided by number of ventricular beats post-treatment)."}

Secondary endpoints

• {"endpoint_text":"- Comparison of the absolute reduction in the number of ventricular beats measured on the 24-h Holter before starting each treatment vs. after reaching the target doses. Analysis will be performed by intention to treat.","definition_or_measurement_approach":"Measured by 24-h Holter-ECG counts before treatment and after reaching target doses; analysis by intention-to-treat."}
• {"endpoint_text":"- Comparison of the % reduction of ectopic ventricular beats over the total number of beats recorded before starting each treatment vs. ECG obtained immediately before stopping said drug, with the previously titrated dose.","definition_or_measurement_approach":"Percentage reduction of ectopic ventricular beats relative to total beats, measured by ECG/Holter before treatment and immediately before stopping drug at titrated dose."}
• {"endpoint_text":"- Comparison of the percentage of patients who achieve a reduction in the number of ventricular extrasystoles greater than 80% in absolute number between both groups.","definition_or_measurement_approach":"Proportion of patients achieving >80% absolute reduction in ventricular extrasystoles, measured by Holter-ECG counts."}
• {"endpoint_text":"- A subgroup study will be carried out for the primary variable depending on the origin of the ventricular arrhythmia.","definition_or_measurement_approach":"Subgroup analysis of the primary endpoint stratified by origin of ventricular arrhythmia (as defined in protocol)."}
• {"endpoint_text":"- Improvement in quality of life with the SF36 questionnaire.","definition_or_measurement_approach":"Quality-of-life measured using the SF36 questionnaire at baseline and end of treatment."}
• {"endpoint_text":"- Change in LVEF and GLS strain (global longitudinal strain) of the left ventricle between the baseline TTE and that performed at the end of treatment with each drug.","definition_or_measurement_approach":"Change in left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS) measured by transthoracic echocardiography (TTE) at baseline and end of treatment."}
• {"endpoint_text":"- Number of patients who present any adverse effect during follow-up with each drug.","definition_or_measurement_approach":"Count of patients reporting any adverse event during follow-up with each drug (safety monitoring)."}
• {"endpoint_text":"- Number of patients with serious adverse effects with each drug. We will understand serious adverse effects as all those that require admission or cause the death of the patient.","definition_or_measurement_approach":"Count of patients with serious adverse events (SAEs) defined as events requiring hospital admission or causing death."}
• {"endpoint_text":"- Descriptives of the pathology.","definition_or_measurement_approach":"Descriptive statistics of disease characteristics (as specified in protocol)."}

Spain

Earliest CTIS Part Ii Submission Date

07-03-2024

Latest Decision Or Authorization Date

02-04-2024

Processing Time Days

26

Number Of Sites

1

Number Of Participants

32

Primary sponsor

Full Name

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain