Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing

• Status: Withdrawn
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this prospective, randomized and controlled trial is to evaluate the use of the ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in single-chamber or dual chambers ICD recipients HF patients with moderate to severe left ventricular dysfunction (FE ≤ 40%) and an heart rate ≥ 70 bpm in sinus rhythm over a 12-months follow up.

Besides the investigators want to assess if the combination of ivabradine to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a lower degree of left ventricular dysfunction progression, the reduction of ventricular arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of life in ICD heart failure patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Policlinico Casilino ASL RMB
• Treatments: Adrenergic beta-Antagonists; Bisoprolol

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.