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Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00202579
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 20, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the effects on heart function of ivabradine administered to patients with severe chronic heart failure

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: Ivabradine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Effects on Peripheral and Central Haemodynamics Parameters, Safety, and Tolerance of Three-hour Intravenous Perfusion (0.1 mg/kg) of Ivabradine Given to Severe Congestive Heart Failure Patients
Study Start Date : September 2004
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Ivabradine
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Haemodynamic parameters
  2. Twelve-lead ECG
  3. Systolic and diastolic blood pressure

Secondary Outcome Measures :
  1. Echocardiography
  2. Neurohormones

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systolic congestive heart failure
  • sinus rhythm, HR >= 80bpm

Exclusion Criteria:

  • unstable cardiovascular condition
Contacts and Locations

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): NCT00202579


Locations
Italy
Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Investigators
Study Chair: Luigi Tavazzi, Pr Policlinico San Matteo
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00202579     History of Changes
Other Study ID Numbers: CL2-16257-053
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: June 2011

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases