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Ivabradine in Hemodialysed Patients With Increased Heart Rate

Primary Purpose

High Heart Rate

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ivabradine
Placebo
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Heart Rate focused on measuring Heart rate, Dialysis, ESRD, ivabradine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Chair of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ivabradine

Control

Arm Description

Outcomes

Primary Outcome Measures

Heart rate

Secondary Outcome Measures

Number of patients that experienced hypotension

Full Information

First Posted
May 25, 2011
Last Updated
June 20, 2012
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT01364077
Brief Title
Ivabradine in Hemodialysed Patients With Increased Heart Rate
Official Title
Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Heart Rate
Keywords
Heart rate, Dialysis, ESRD, ivabradine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo
Primary Outcome Measure Information:
Title
Heart rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of patients that experienced hypotension
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dialysis patients Sinus rhythm Pre-dialytic Heart rate > 80 bpm Exclusion Criteria: Atrial fibrillation/atrial flutter Heart failure Valvular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gennaro Cice, MD
Organizational Affiliation
Second Univesity of Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chair of Cardiology
City
Naples
ZIP/Postal Code
80100
Country
Italy

12. IPD Sharing Statement

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Ivabradine in Hemodialysed Patients With Increased Heart Rate

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