Ivabradine in Hemodialysed Patients With Increased Heart Rate

High Heart Rate Clinical Trial

Official title:

Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01364077
• Other study ID #: IV-DIAL.01
• Secondary ID: IV-DIAL.01-A
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 25, 2011
• Last updated: June 20, 2012
• Start date: January 2010

Study information

• Verified date: June 2012
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A significant association between resting heart rate (HR) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease.

Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study reported that the 48-hr mean HR is an independent predictor of cardiovascular events in normotensive hemodialysis patients.

Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial antianginal effects and mortality reduction linked to HR reduction in ischemic patients.

Aim:

To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (> 80 bpm)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Dialysis patients

• Sinus rhythm

• Pre-dialytic Heart rate > 80 bpm

Exclusion Criteria:

• Atrial fibrillation/atrial flutter

• Heart failure

• Valvular disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Heart Rate
• Tachycardia

Intervention

Drug:
• Ivabradine
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
• Placebo
Matched placebo

Locations

Country	Name	City	State
Italy	Chair of Cardiology	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate		1 year	No
Secondary	Number of patients that experienced hypotension		1 year	Yes