Efficacy of Ivabradine in Patient With Both Persistent Atrial Fibrillation and Heart Failure With Reduce Ejection Fraction
Atrial Fibrillation, Ivabradine, Heart Failure
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- The patient with persistent or permanent atrial fibrillation(24hr ECG) with HFrEF and HFmrEF.
- After maximal tolerance dose beta-blocker(Bisoprolol 20mg/day,Carvedilol 50mg/day) or intolerant to beta-blocker the resting heart rate from ECG is still faster than 100 or resting heart rate from ECG is greater than 80 but still with symptoms of short of breath and palpitation.
- Stable heart rhythm medication.(no change of medication in recently one week)
- Age 20 to 90 years old.
- The subject must be an adult who can read himself/herself and walk independently.
Exclusion Criteria:
- Used medication with interaction with digoxin : Clarithromycin, Erythromycin, Azithromycin, ritonavir, lopinavir/ritonavir, Doxycycline, Minocycline, tetracycline。
- Used medication with interaction with ivabradine: voriconazole, posaconazole, fluconazole, Ombitasvir, Dasabuvir, Carbamazepine, Enzalutamide, Fosphenytoin, Mitotane, Phenobarbital, Phenytoin, Rifampicin
- Cardiogenic shock.
- History of symptomatic bradycardia.
- Renal insufficiency:eGFR<30 ml/min/1.73m2
- Pregnancy
- Heart failure due to congenital heart
- Severe hypotension(<90/50mmHg)
Sites / Locations
- Taipei Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ivabradine
Digoxin
Subject will be randomly assigned to either Ivabradine or Digoxin group. Ivabradine starting dose is 2.5 mg twice daily(BID). ECG will be performed at each visit during the treatment phase and dose will be adjusted based on the heart rate result from the ECG. Total treatment phase is 16 weeks ( 4 months).
Subject will be randomly assigned to either Ivabradine or Digoxin group. Digoxin starting dose is 0.125mg once daily(QD) in estimated Glomerular filtration rate(eGFR)>60, 0.125mg every other day (QOD) in estimated Glomerular filtration rate(eGFR)<60. Dose adjustment will be based on heart rate result from ECG performed at each treatment visit and Digoxin level from blood sample collected from each visit during treatment phase. Total treatment phase is 16 weeks ( 4 months).