Status:
WITHDRAWN
Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing
Lead Sponsor:
Policlinico Casilino ASL RMB
Conditions:
Heart Rate Control in ICD Patients With Heart Failure
Eligibility:
All Genders
18-95 years
Phase:
PHASE4
Brief 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 (bis...
Detailed Description
Background High heart rate (HR) represent per se a risk factor for cardiovascular mortality and heart failure (HF) progression, despite optimal HF therapy. Beta-blockers remain the therapy of choice ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01868880
Start Date
February 1 2016
End Date
December 1 2023
Last Update
March 13 2020
Active Locations (1)
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1
Polinico Casilino
Rome, Italy, 00169