Ivabradine in Hemodialysed Patients With Increased Heart Rate

NCT ID: NCT01364077

Last Updated: 2012-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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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)

Detailed Description

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Conditions

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High Heart Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ivabradine

Group Type ACTIVE_COMPARATOR

Ivabradine

Intervention Type DRUG

Ivabradine 5 mg BID titrated to 7.5 mg if tolerated

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo

Interventions

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Ivabradine

Ivabradine 5 mg BID titrated to 7.5 mg if tolerated

Intervention Type DRUG

Placebo

Matched placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Atrial fibrillation/atrial flutter
* Heart failure
* Valvular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Gennaro Cice

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gennaro Cice, MD

Role: PRINCIPAL_INVESTIGATOR

Second Univesity of Naples

Locations

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Chair of Cardiology

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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IV-DIAL.01-A

Identifier Type: OTHER

Identifier Source: secondary_id

IV-DIAL.01

Identifier Type: -

Identifier Source: org_study_id

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