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Efficacy of Ivabradine as a Treatment Modality for Both Rate Control and Heart Failure Medication in Patient With Both Persistent Atrial Fibrillation and Heart Failure With Reduce and Mid-range Ejection Fraction
Sponsor study identifier
interventional
100
1 country
1
Study Start
August 26, 2018
Actual (reported)Primary Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. Previous studies have shown that rate control strategy in AF is non-inferior to rhythm control strategy, in terms of stroke and mortality risk. In addition, rate control strategy is associated with lower risk of hospitalization and non-cardiovascular mortality. Therefore, rate control is an essential strategy to improve quality of life, decrease morbidity and prevent tachycardia-induced cardiomyopathy in AF patients. The recommended rate control agents include beta-blocker, nondihydropyridine calcium-channel blocker (CCB), digoxin and amiodarone. However, in heart failure with reduced ejection fraction patient, the medication of rate control were beta-blocker than digoxin. But several clinical observation study show excess mortality in AF patients. Ivabradine, a If inhibitor, it is well-established that a pacemaker current, If current, is functionally expressed in the sinus node . Previous studies have shown that Ivabradine, If inhibitor, significantly reduces sinus rate and improves prognosis in patients with systolic heart failure. Interestingly, several investigators found that hyperpolarization- activated cyclic nucleotidylated channel 4 current (HCN4), the main isoform of the channel responsible for If current, is also functionally expressed in the Atrioventricular node(AV node). Recent data have shown that inhibition of If current slows AV node conduction in animals and humans. Thus, we want to compare the effect of Ivabradine on ventricular rate with digoxin in this study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 2018
Actual (reported)May 9, 2019
Actual (reported)March 13, 2020
Actual (reported)December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Heart rate change
To compare Heart Rate change monitored from 24 hr ECG. Test will be performed at Baseline (screening phase, 4 weeks time between screening/Informed consent and Randomization visit) and treatment completion (Visit 5/Week 16). Total treatment phase is 16 weeks.
24 hr ECG test will be performed at Screening phase and End of Treatment visit(Visit5/Week 16).
6 minute walk test change
To compare 6 minute walking test walking distance change between Randomization visit(Visit 1/Week 0) and treatment completion(Visit 5/Week 16). Total Treatment phase is 16 weeks.
Test will be performed at Randomization visit (V1/Week0) and treatment completion (Visit 5/Week 16).
N-terminal pro-brain natriuretic peptide(NT-Pro BNP) change
To compare NT-Pro BNP change from blood sample collected at Baseline (screening phase, 4 weeks time between screening/informed consent and Randomization visit) and treatment completion (Visit 5/Week 16). Total treatment phase is 16 weeks.
Blood sample will be collected at Screening phase and End of Treatment visit(Visit5/Week 16).
1-10 Borg Rating of Perceived Exertion Scale change
To compare 1-10 Borg Rating of Perceived Exertion Scale change between Randomization visit (Visit1/Week0) and treatment completion (Visit 5/Week 16). Total Treatment phase is 16 weeks. The number 1-10 Borg Rating of Perceived Exertion Scale will be obtained pre and post 6 minutes walk test. The value of 1-10 Borg Rating of Perceived Exertion Scale pre 6 minutes walking test will be compared between Randomization visit (Visit1/Week0) and treatment completion (Visit 5/Week 16), and the same type of comparison will be performed for 1-10 Borg Rating of Perceived Exertion Scale values post 6 minute walk test. Rating score is as below: 0=Rest, 1=really easy, 2=easy, 3=moderate, 4=sort of hard, 5=hard, 6= between 5 and 7, 7=really hard, 8=between 7 and 9, 9=really really hard, 10=Maximal: just like my hardest race. Decrease in score value compared between Randomization visit (Visit1/Week0) and treatment completion (Visit 5/Week 16) represents better outcome.
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).
Starting dose: Ivabradine 2.5mg twice daily (BID) Max Dose: Ivabradine 7.5 mg twice daily (BID)
Starting dose: 0.125mg once daily (QD) in estimated Glomerular filtration rate(eGFR)\>60， 0.125mg once every other day (QOD) in estimated Glomerular filtration rate(eGFR)\<60 Max dose: 0.25 once daily (QD)
Taipei Medical University Hospital
Taipei, Taiwan
First Submitted
May 9, 2019
First Posted
March 13, 2020
Study Start
August 26, 2018
Actual (reported)Primary Completion
December 31, 2020
Estimated (date passed)Borg's score will be tested at Randomization visit (V1/Week0) and treatment completion (Visit 5/Week 16).
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 13, 2020
Record last verified: 2020-03
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