Ivabradine in Hemodialysed Patients With Increased Heart Rate

June 20, 2012 updated by: Gennaro Cice, University of Campania "Luigi Vanvitelli"

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

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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 Locations

  • Italy
      • Naples, Italy, 80100
        • Chair of Cardiology

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dialysis patients
  • Sinus rhythm
  • Pre-dialytic Heart rate > 80 bpm

Exclusion Criteria:

  • Atrial fibrillation/atrial flutter
  • Heart failure
  • Valvular disease

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Drug: Placebo
Matched placebo
Active Comparator: Ivabradine
Drug: Ivabradine
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients that experienced hypotension
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University of Campania "Luigi Vanvitelli"

Investigators

  • Principal Investigator: Gennaro Cice, MD, Second Univesity of Naples

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

January 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 25, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IV-DIAL.01
  • IV-DIAL.01-A (Other Identifier: Second Univesity of Naples)

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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