IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE… (NCT03718273) | Clinical Trial Compass
CompletedPhase 3
IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE-AF Study).
Spain68 participantsStarted 2018-10-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years.
✓. Permanent Atrial Fibrillation (AF) at the time of randomization, with no prospect of cardioversion, antiarrhythmic treatment with group I or III drugs, or pulmonary vein ablation.
✓. Symptoms attributable to AF associated with the presence of at least one of the following inadequate Heart rate (HR) control criteria:
✓. HR at rest \> 110 bpm (on ECG -electrocardiogram- performed in the 14 days prior to inclusion).
✓. HR at rest between 80 and 110 bpm (on ECG performed in the 14 days prior to inclusion) and at least one of the following criteria:
✓. Be receiving treatment with beta-blockers or non-dihydropyridine calcium channel blockers (verapamil or diltiazem) at the maximum dose recommended or tolerated by the patient.
✓. Be able to voluntarily give their informed consent.
✓. B\|ood test carried out in the 6 months prior to inclusion' including: blood count, thyroid hormones and creatinine, in order to rule out secondary causes of poor HR control. The creatinine figure will be used to calculate the creatinine clearance in order to adjust the dose of patients who are randomized to the Digoxin group.
Exclusion criteria
✕. Previous treatment or patients with a known contraindication to Ivabradine or Digoxin or to any excipient of both drugs.
✕. Paroxysmal or intermittent complete atrioventricular (AV) block in patients not carrying a pacemaker.
✕. Decompensated heart failure requiring inotropic and I or intravenous diuretics in the week prior to randomization or in New York Heart Association (NYHA) functional class IV or on the cardiac transplant waiting list,
✕. Acute pericarditis, acute myocarditis or constrictive pericarditis.
✕. Obstructive hypertrophic cardiomyopathy.
✕. Valvular disease requiring surgical or percutaneous correction.
✕. Medical causes that justify poor control of heart rate: fever' anemia, hyperthyroidism, pheochromocytoma' etc.
✕. Severe hypotension (blood pressure \<90/50 mmHg).