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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Medical University of Warsaw
Sponsor:
Information provided by (Responsible Party):
Marcin Grabowski, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT02166060
First received: June 10, 2014
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: Ivabradine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Percentage of biventricular pacing >95% [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of biventricular pacing >98% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to first inappropriate shock [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • change of mean heart rate compared with baseline [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Cardiovascular hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • The change between baseline and final echocardiographic parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The assessment of quality of life (SF36) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The change between baseline and final NYHA class [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Procoralan

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02166060

Contacts
Contact: Marcin Grabowski, PhD +48 660 751 816 marcin.grabowski@wum.edu.pl
Contact: Lukasz Januszkiewicz, MD +48 694 333 056 lukasz.jan.januszkiewicz@gmail.com

Locations
Poland
1st Department of Cariology of Medcial University of Warsaw Not yet recruiting
Warsaw, Mazowieckie, Poland, 02-097
Principal Investigator: Marcin Grabowski, MD         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Study Chair: Marcin Grabowski, MD Medical University of Warsaw
  More Information

No publications provided

Responsible Party: Marcin Grabowski, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02166060     History of Changes
Other Study ID Numbers: IvaCRT KB/111/2014
Study First Received: June 10, 2014
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration
Poland: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014