Hemodialysis patients with chronic heart failure whose resting heart rate is 75 beats per minute or higher
Conditions
Interventions
Ivabradine hydrochloride
Sponsors
Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients with chronic heart failure in sinus rhythm and a resting heart rate of 75 beats per minute or greater at the time of consent 2. patients receiving standard therapy for chronic heart failure including beta-blockers at the time of consent (including beta-blocker intolerant patients) 3. male or female, 20 years of age or older at the time of consent 4. patients undergoing hemodialysis for more than 12 weeks at the time of consent. 5. patients who have given their written consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. patients with a history of hypersensitivity to any component of ivabradine hydrochloride 2. patients with unstable or acute heart failure 3. patients with cardiogenic shock 4. patients with severe hypotension (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 50 mmHg) 5. patients with atrial fibrillation 6. patients with sinus failure syndrome, sinoatrial block, or third degree atrioventricular block 7. patients with severe hepatic dysfunction 7) Patients with severe hepatic dysfunction (Child-Pugh C) 8. patients receiving the following drugs: ritonavir-containing products, josamycin, itraconazole, clarithromycin, cobicistat-containing products, indinavir, voriconazole, nelfinavir, saquinavir, telaprevir 9. patients who are pregnant, lactating, may be pregnant or plan to become pregnant 10. patients who are receiving verapamil or diltiazem 11. patients who are scheduled to undergo surgical treatment during the study period 12. 12. patients who require a substitute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in resting heart rate from baseline to 12 weeks post-dose | — |
Countries
Japan
Contacts
Public ContactSayuri Kawasaki
Nippon Medical School Department of Nephrology
Outcome results
None listed