Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing
Heart Rate Control in ICD Patients With Heart Failure
About this trial
This is an interventional treatment trial for Heart Rate Control in ICD Patients With Heart Failure
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years.
Patients with stable chronic heart failure implanted with mono-cameral or bicameral ICD with a home monitoring remote control.
Moderate to severe left ventricular dysfunction (FE ≤ 40%).
Any cause of heart failure was allowed apart congenital heart disease.
Bicameral ICD programmed in DDD or AAI/DDD with AV interval < 300 msec.
Rest ECG heart rate ≥70 bpm;
Sinus rhythm.
In therapy with low-dose of beta-blocker (bisoprolol 1,25-2,5 mg) and with the maximum dose tolerated of angiotensin-converting enzyme inhibitor or blockade of angiotensin II receptor, mineralocorticoid antagonist, antiplatelet and lipid-lowering therapy, unless contraindicated.
Exclusion Criteria:
Inability of providing informed consent;
Age < 18 years.
State of pregnancy or lactation.
Recent (<2 months) myocardial infarction;
Contraindications to beta-blockers and ivabradine;
Rest ECG heart rate < 70 bpm;
No sinus rhythm.
Administration of non-dihydropyridinic calcium channels antagonists, digitalis, class I antiarrhythmic drugs, strong inhibitors of cytochrome P450 3A4 at the time of enrollment.
Sites / Locations
- Polinico Casilino
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ivabradine plus beta-blocker(bisoprolol)
beta-blocker (bisoprolol) titration
Ivabradine will be administered at a dose of 5 mg twice daily in addition to a low dose of beta-blocker (bisoprolol 1,25 or 2,5 mg). After four weeks of treatment ivabradine will be eventually lowered up to 2,5 mg twice daily in the presence of side effects (phosphenes, diplopia, headache or dizziness).
Beta blocker Bisoprolol will be titrated biweekly starting from the initial dose of 1,25-2,5 mg daily up to the max dose of 10 mg daily or to the maximum tolerated dose.