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Carvedilol vs. flecainida clinical trial in idiopathic ventricular arrhythmias.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510362-26-00
Acronym
CARFLECT IV
Enrollment
32
Registered
2024-04-02
Start date
2024-06-11
Completion date
Unknown
Last updated
2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic ventricular arrhythmias

Brief summary

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.

Detailed description

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., 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., 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., A subgroup study will be carried out for the primary variable depending on the origin of the ventricular arrhythmia., Improvement in quality of life with the SF36 questionnaire., 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., Number of patients who present any adverse effect during follow-up with each drug., 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., Descriptives of the pathology.

Interventions

DRUGCARVEDILOL
DRUGFLECAINIDE

Sponsors

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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., 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., 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., A subgroup study will be carried out for the primary variable depending on the origin of the ventricular arrhythmia., Improvement in quality of life with the SF36 questionnaire., 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., Number of patients who present any adverse effec

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026