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Ivabradine in Hemodialysed Patients With Increased Heart Rate

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ClinicalTrials.gov Identifier: NCT01364077
Recruitment Status : Unknown
Verified June 2012 by Gennaro Cice, Second University of Naples.
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2011
Last Update Posted : June 21, 2012
Sponsor:
Information provided by (Responsible Party):
Gennaro Cice, Second University of Naples

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)


Condition or disease Intervention/treatment Phase
High Heart Rate Drug: Ivabradine Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate
Study Start Date : January 2010
Actual Primary Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ivabradine
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Heart rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of patients that experienced hypotension [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364077


Locations
Italy
Chair of Cardiology
Naples, Italy, 80100
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
Principal Investigator: Gennaro Cice, MD Second Univesity of Naples

Responsible Party: Gennaro Cice, MD, Second University of Naples
ClinicalTrials.gov Identifier: NCT01364077     History of Changes
Other Study ID Numbers: IV-DIAL.01
IV-DIAL.01-A ( Other Identifier: Second Univesity of Naples )
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Gennaro Cice, Second University of Naples:
Heart rate
Dialysis
ESRD
ivabradine

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes