Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy

Phase 4

• Conditions: Heart Failure
• Interventions: Drug: Ivabradine

• Registration Number: NCT02166060
• Lead Sponsor: Medical University of Warsaw

Brief Summary

The purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing.

The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who received CRT-D device more than 3 months ago. Patients with biventricular pacing \<95% will and heart rate \<70 at rest and \>50% of heart rate in device memory \>70 will receive ivabradine. The minimal follow-up of patients in the study will be at least six months.

Detailed Description

Approximately 30% of CRT recipients do not respond to therapy. One of the causes ot that is unsatisfactory percentage of biventricular pacing. Patients may loose biventricular pacing because of inadequate sinus tachycardia.

Ivabradine may prevent inadequate sinus tachycardia and improve quality of live of CRT recipients.

According to current guidelines ivabradine is recommended in patients with symptomatic heart failure with heart rate at rest \>70.

The hypothesis of this study is that ivabradine may increase percentage of biventricular pacing in CRT recipients who have unsatisfactory percentage of biventricular pacing and \>50% of heart rate in device memory \>70.

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-13
• Last Update Submitted: 2014-06-13
• Study First Posted: 2014-06-18
• Last Update Posted: 2014-06-18
• Study Start: 2014-08
• Primary Completion: 2016-08
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• heart failure NYHA II-IV
• left ventricular ejection fraction =<35%
• CRT-D implanted over 3 months ago
• optimal CRT-D parameters
• biventricular pacing <95% despite the optimal parameters of the device
• optimal pharmacotherapy with the highest well-tolerated beta-adrenolytic dosage
• heart rate at rest below 70 bpm
• over 50% of heart rhythm over 70 bpm at interrogation with the device

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Exclusion Criteria

• persistent atrial fibrillation/flutter
• device associated ineffective resynchronization
• contraindications to ivabradine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ivabradine	Ivabradine	Ivabradine 5 mg twice a day or 7,5 mg twice a day

Primary Outcome Measures

Name	Time	Method
Percentage of biventricular pacing >95%	6 months

Secondary Outcome Measures

Name	Time	Method
Percentage of biventricular pacing >98%	6 months
Time to first inappropriate shock	6 months
change of mean heart rate compared with baseline	6 months
Cardiovascular hospitalization	6 months
The change between baseline and final echocardiographic parameters	6 months
The assessment of quality of life (SF36)	6 months
The change between baseline and final NYHA class	6 months

Trial Locations

Locations (1)

1st Department of Cariology of Medcial University of Warsaw; 🇵🇱 Warsaw, Mazowieckie, Poland