IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE-AF Study).

PHASE3CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

October 19, 2018

Primary Completion Date

February 22, 2022

Study Completion Date

June 30, 2022

Conditions
Atrial FibrillationHeart Diseases
Interventions
DRUG

Ivabradine

"Ivabradine 5 mg, twice a day the first month administered by mouth. If the tolerance is good, the dose will be increased to 7.5 mg on month 2 and will continue until the third month.~Patients with 75 or more years of age will receive an initial dose of 2.5 mg / twice a day, which can be increased to 5 mg / twice a day in week 7 and to 7.5 mg in month 1 if the tolerance has been good"

DRUG

Digoxin

The initial dose will be based on whether there are factors such as age over 80 years, weight less than 60 kg and creatinine clearance \<60ml / min, if there is no factor, the oral dose will be 0.25mg / 24h. If there are 2 factors, the dose will be 0.15 mg / 24 h. and if there are 2 or 3 factors, the dose will be 0.10 mg / 24 h.

Trial Locations (10)

28022

Hospital Universitario Puerta de Hierro, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Fundación Jiménez Díaz, Madrid

Hospital Clínico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28905

Hospital Universitario de Getafe, Madrid

28933

Hospital Universitario Rey Juan Carlos, Madrid

45004

Hospital Virgen de la Salud, Toledo

09006

Hospital Universitario de Burgos, Burgos

All Listed Sponsors
collaborator

Spanish Clinical Research Network - SCReN

NETWORK

collaborator

Carlos III Health Institute

OTHER_GOV

lead

Adolfo Fontenla

OTHER

NCT03718273 - IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE-AF Study). | Biotech Hunter | Biotech Hunter