The BRAKE-AF Study is a phase III, randomised, controlled, multicentric, open-label clinical trial to prove the noninferiority of ivabradine versus digoxin in the treatment of permanent atrial fibrillation. The total duration of the study is 3 years, with 24 months of enrolment, treatment and follow-up.
This is a non-commercial, investigator-driven clinical study funded through a public competitive call by Instituto de Salud Carlos III, Spanish Ministry of Economy (PI17/01272). The study is coordinated by the main investigator from Hospital Universitario 12 de Octubre in Madrid; the sponsorship is performed by Dr. Adolfo Fontenla (Hospital Universitario 12 de Octubre). Several responsibilities are delegated to the Clinical Research Unit (Hospital 12 de Octubre, Madrid, Spain). The study was planned according to the Good Clinical Practices. BRAKE-AF Study has been approved by the Ethics Committee and Spanish Health Authorities. All participating patients must give written informed consent before any study procedure occur.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
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
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.
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Fundación Jiménez Díaz
Madrid, Spain
Heart rate reduction.
Reduction of the mean daytime heart rate registered in Holter- electrocardiogram (ECG) after treatment with Ivabradine or Digoxin.
Time frame: 3 months
Serious adverse events
Proportion of patients experiencing syncope, severe bradycardia or any serious adverse reaction requiring hospitalization, emergency visit or death of the patient during treatment with Ivabradine or Digoxin.
Time frame: 3 months
Reduction in the scale of atrial fibrillation (AF) symptoms according to the European Hearth Rhythm Association (EHRA) Score modified.
Percentage of patients who experience a reduction in the scale of atrial fibrillation. symptoms according to the EHRA Score modified.
Time frame: Months 1 and 3.
6 minute walk test (6MWT).
Increase in meters in the 6MWT.
Time frame: Baseline and after 3 months.
Quality-of-Life Short Form 36 (SF-36) Health Survey (QoL SF-36) Score.
Increase in the score obtained in global quality of life parameters analyzed by the SF-36 questionnaire.
Time frame: At baseline and 3 months.
The Atrial Fibrillation Effect on Quality-of-Life (QoL AFEQT) score.
Increase in the score obtained in parameters of quality of life quality of life associated with AF analyzed by the AFEQT questionnaire.
Time frame: At baseline and 3 months
Reduction of the daytime Health rate.
Reduction of the average daytime Heart Rate (HR) recorded in Holter-ECG
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Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario de Getafe
Madrid, Spain
Hospital Universitario Rey Juan Carlos
Madrid, Spain
Hospital Virgen de la Salud
Toledo, Spain
Time frame: 1 month
Reduction of resting Health Rate.
Reduction of resting heart rate (HR) recorded on one electrocardiogram (ECG).
Time frame: 1 and 3 months
Reduction of the maximum heart rate (HR) recorded.
Reduction of the maximum HR recorded in Holter-ECG
Time frame: 1 and 3 months
Reduction of the mean HR recorded.
Reduction of the mean HR in 24 hours recorded in Holter-ECG .
Time frame: 1 and 3 months
Reduction of the HR delta.
Reduction of the HR delta (difference between maximum HR and mean HR in 24 hours) recorded in Holter-ECG.
Time frame: 1 and 3 months
Reduction of HR in moderate exercise.
Reduction of HR in moderate exercise (maximum HR measured by Holter-ECG during the 6-minute walk test.
Time frame: 3 months
Percentage of patients with non-severe bradycardia.
Percentage of patients who experience non-severe bradycardia during the study treatment.
Time frame: 1 and 3 months
Percentage of patients who experience any adverse reaction.
Percentage of patients who experience any adverse reaction to the study drugs.
Time frame: 1 and 3 months
Percentage of patients who voluntarily abandon the study drugs.
Percentage of patients who voluntarily abandon the study drugs.
Time frame: 3 months
Proportion of hospitalizations, emergency visits and mortality due to a major cardiovascular event.
Proportion of patients experiencing hospitalizations, emergency visits and mortality due to a major cardiovascular event during treatment with the study drug.
Time frame: 3 months