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Ivabradine in Hemodialysed Patients With Increased Heart Rate

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Gennaro Cice, Second University of Naples.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Gennaro Cice, Second University of Naples Identifier:
First received: May 25, 2011
Last updated: June 20, 2012
Last verified: June 2012

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.


To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (> 80 bpm)

Condition Intervention Phase
High Heart Rate Drug: Ivabradine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Gennaro Cice, Second University of Naples:

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

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

Estimated Enrollment: 100
Study Start Date: January 2010
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ivabradine Drug: Ivabradine
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
Placebo Comparator: Control Drug: Placebo
Matched placebo


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Atrial fibrillation/atrial flutter
  • Heart failure
  • Valvular disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01364077

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

Responsible Party: Gennaro Cice, MD, Second University of Naples Identifier: NCT01364077     History of Changes
Other Study ID Numbers: IV-DIAL.01
IV-DIAL.01-A ( Other Identifier: Second Univesity of Naples )
Study First Received: May 25, 2011
Last Updated: June 20, 2012

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 21, 2017