Carvedilol vs. flecainida clinical trial in idiopathic ventricular arrhythmias.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

11 Jun 2024 → ongoing

Decision date (initial)

2024-04-02

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

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.

Secondary objectives 8

1. Compare the absolute reduction in the number of ventricular beats recorded before starting each treatment vs. after completing 12 weeks with the drug. Analysis will be performed by intention to treat.
2. Comparison of the % reduction of ectopic ventricular beats over the total number of beats recorded before starting each treatment vs. after completing 12 weeks with the drug.
3. 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.
4. A subgroup study will be carried out for the primary variable depending on the origin of the ventricular arrhythmia.
5. Improvement in quality of life with the SF36 questionnaire.
6. Change in LVEF and GLS Strain of the left ventricle between the baseline TTE and that performed at the end of treatment with each drug.
7. Number of patients who present any adverse effect during follow-up with each drug.
8. 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.

Conditions and MedDRA coding

Idiopathic ventricular arrhythmias

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients of legal age capable of consenting.

Exclusion criteria 15

1. Allergy or adverse effects after previously taking flecainide and/or carvedilol.
2. 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.
3. 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.
4. Liver failure.
5. Chronic kidney disease with glomerular filtration rate <30 ml/m2/min.
6. Second or third degree atrioventricular block.
7. First degree atrioventricular block with PR >220 ms.
8. Duration of the QRS complex >120 ms.
9. Moderately or severely depressed left ventricular ejection fraction (<40%).
10. Significant heart failure secondary to tachemocardiopathy.
11. 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).
12. Sinus dysfunction in patients who do not have pacemakers.
13. Presence of accessory roads.
14. 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.
15. Having received electrophysiological procedures will only be an exclusion criterion if it was performed to ablate malignant ventricular arrhythmias.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 9

1. 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.
2. 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.
3. 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.
4. A subgroup study will be carried out for the primary variable depending on the origin of the ventricular arrhythmia.
5. Improvement in quality of life with the SF36 questionnaire.
6. 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.
7. Number of patients who present any adverse effect during follow-up with each drug.
8. 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.
9. Descriptives of the pathology.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Sponsor organisation

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Address

Travesia Da Choupana S/n

City

Santiago De Compostela

Postcode

15706

Country

Spain

Scientific contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Contact name

Moisés Rodríguez Mañero

Public contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Contact name

Moisés Rodríguez Mañero

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications