Clinical trial NCT02166060: Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
Official title: Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of biventricular pacing >95%
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of biventricular pacing >98%
timeFrame: 6 months
measure: Time to first inappropriate shock
timeFrame: 6 months
measure: change of mean heart rate compared with baseline
timeFrame: 6 months
measure: Cardiovascular hospitalization
timeFrame: 6 months
measure: The change between baseline and final echocardiographic parameters
timeFrame: 6 months
measure: The assessment of quality of life (SF36)
timeFrame: 6 months
measure: The change between baseline and final NYHA class
timeFrame: 6 months
Other outcomes:
measure: Number of participants with adverse events
timeFrame: 6 months
Locations:
city: Warsaw
country: Poland
facility: 1st Department of Cariology of Medcial University of Warsaw
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw
name: Marcin Grabowski, MD
role: STUDY_CHAIR
References: