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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 : March 15, 2018
Sponsor:
Information provided by:
Servier

Study Description
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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
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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
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Ivabradine

Arms and Interventions
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Outcome Measures
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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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
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Italy
Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Investigators
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Study Chair: Luigi Tavazzi, Pr Policlinico San Matteo
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00202579    
Other Study ID Numbers: CL2-16257-053
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: http://clinicaltrials.servier.com
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases