Ivabradine in Hemodialysed Patients With Increased Heart Rate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Second University of Naples.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Gennaro Cice, Second University of Naples
ClinicalTrials.gov Identifier:
NCT01364077
First received: May 25, 2011
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Second University of Naples:

Primary Outcome Measures:
  • Heart rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients that experienced hypotension [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT01364077

Locations
Italy
Chair of Cardiology
Naples, Italy, 80100
Sponsors and Collaborators
Second University of Naples
Investigators
Principal Investigator: Gennaro Cice, MD Second Univesity of Naples
  More Information

No publications provided

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
Study First Received: May 25, 2011
Last Updated: June 20, 2012
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 29, 2014