Trials / Unknown
UnknownNCT02166060
Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Medical University of Warsaw · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ivabradine | Ivabradine 5 mg twice a day or 7,5 mg twice a day |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2016-08-01
- Completion
- 2016-10-01
- First posted
- 2014-06-18
- Last updated
- 2014-06-18
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT02166060. Inclusion in this directory is not an endorsement.