Ivabradine in Hemodialysed Patients With Increased Heart Rate
NCT ID: NCT01364077
Last Updated: 2012-06-21
Study Results
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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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2010-01-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ivabradine
Ivabradine
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
Control
Placebo
Matched placebo
Interventions
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Ivabradine
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
Placebo
Matched placebo
Eligibility Criteria
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Inclusion Criteria
* Sinus rhythm
* Pre-dialytic Heart rate \> 80 bpm
Exclusion Criteria
* Heart failure
* Valvular disease
18 Years
85 Years
ALL
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Gennaro Cice
MD
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
Countries
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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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