Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

— IvaCRT  

Official title:

Ivabradine in Patients With an Unsatisfactory Percentage of Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02166060
• Other study ID #: IvaCRT KB/111/2014
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 10, 2014
• Last updated: June 13, 2014
• Start date: August 2014
• Est. completion date: October 2016

Study information

• Verified date: June 2014
• Source: Medical University of Warsaw
• Contact: Marcin Grabowski, PhD
• Phone: +48 660 751 816
• Email: marcin.grabowski[@]wum.edu.pl
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Ivabradine
Ivabradine 5 mg twice a day or 7,5 mg twice a day

Locations

Country	Name	City	State
Poland	1st Department of Cariology of Medcial University of Warsaw	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events		6 months	Yes
Primary	Percentage of biventricular pacing >95%		6 months	No
Secondary	Percentage of biventricular pacing >98%		6 months	No
Secondary	Time to first inappropriate shock		6 months	Yes
Secondary	change of mean heart rate compared with baseline		6 months	Yes
Secondary	Cardiovascular hospitalization		6 months	Yes
Secondary	The change between baseline and final echocardiographic parameters		6 months	No
Secondary	The assessment of quality of life (SF36)		6 months	No
Secondary	The change between baseline and final NYHA class		6 months	No