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Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy (IvaCRT)

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Ivabradine
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1st Department of Cariology of Medcial University of Warsaw

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ivabradine

Arm Description

Ivabradine 5 mg twice a day or 7,5 mg twice a day

Outcomes

Primary Outcome Measures

Percentage of biventricular pacing >95%

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2014
Last Updated
June 13, 2014
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02166060
Brief Title
Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
Acronym
IvaCRT
Official Title
Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine
Arm Type
Experimental
Arm Description
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Other Intervention Name(s)
Procoralan
Intervention Description
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Primary Outcome Measure Information:
Title
Percentage of biventricular pacing >95%
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of biventricular pacing >98%
Time Frame
6 months
Title
Time to first inappropriate shock
Time Frame
6 months
Title
change of mean heart rate compared with baseline
Time Frame
6 months
Title
Cardiovascular hospitalization
Time Frame
6 months
Title
The change between baseline and final echocardiographic parameters
Time Frame
6 months
Title
The assessment of quality of life (SF36)
Time Frame
6 months
Title
The change between baseline and final NYHA class
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcin Grabowski, PhD
Phone
+48 660 751 816
Email
marcin.grabowski@wum.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Lukasz Januszkiewicz, MD
Phone
+48 694 333 056
Email
lukasz.jan.januszkiewicz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Grabowski, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Chair
Facility Information:
Facility Name
1st Department of Cariology of Medcial University of Warsaw
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-097
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcin Grabowski, MD

12. IPD Sharing Statement

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Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy

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