Carvedilol vs. flecainida clinical trial in idiopathic ventricular arrhythmias.

Phase 1

Recruiting

• Conditions: Idiopathic ventricular arrhythmias; MedDRA version: 20.0Level: PTClassification code: 10047289Term: Ventricular extrasystoles Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code: 10058185Term: Monomorphic ventricular tachycardia Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-510362-26-00
• Lead Sponsor: Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Patients of legal age capable of consenting.

Exclusion Criteria

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%).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified