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

June 13, 2014 updated by: Marcin Grabowski, Medical University of Warsaw

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-097
        • 1st Department of Cariology of Medcial University of Warsaw
        • Principal Investigator:
          • Marcin Grabowski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivabradine
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Drug: Ivabradine
Ivabradine 5 mg twice a day or 7,5 mg twice a day
Other Names:
  • Procoralan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of biventricular pacing >95%
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Marcin Grabowski, MD, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

June 18, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IvaCRT KB/111/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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