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Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study (SHIFT)

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ClinicalTrials.gov Identifier: NCT02441218
Recruitment Status : Completed
First Posted : May 12, 2015
Results First Posted : June 29, 2015
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Study Description
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Brief Summary:
The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Ivabradine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6505 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2006
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

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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Arm Intervention/treatment
Experimental: Ivabradine Drug: Ivabradine
2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Placebo Comparator: Placebo Drug: Placebo
Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure. [ Time Frame: All over the study (up to 42 months). ]
    Number of patients having experienced the Primary Composite Endpoint.


Secondary Outcome Measures :
  1. Cardiovascular Death [ Time Frame: From the date of randomization until the date of death, up to 42 months ]
    Component of the primary composite endpoint

  2. Hospitalisation for Worsening Heart Failure [ Time Frame: From the date of randomization to the date of first documented hospitalisation, up to 42 months ]
  3. All-cause Mortality [ Time Frame: From the date of randomisation to death, up to 42 months. ]
  4. Death From Heart Failure [ Time Frame: From the date of randomisation to death, up to 42 months. ]
    Component of cardiovascular death

  5. Hospitalisation for Any Cause [ Time Frame: From the date of randomisation to the date of first documented hospitalisation, up to 42 months ]
  6. Hospitalisation for Cardiovascular Reason [ Time Frame: From the date of randomisation to the first documented hospitalisation, up to 42 months ]
  7. Unplanned Hospitalisation for Any Cause [ Time Frame: From the date of randomisation to the first documented hospitalisation, up to 42 months ]
  8. Unplanned Hospitalisation for CV Reason [ Time Frame: From the date of randomisation to the first documented hospitalisation, up to 42 months. ]
  9. Secondary Composite Endpoint [ Time Frame: From the date of randomisation to the date of the first event, up to 42 months ]
    CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic Chronic heart failure (NYHA II, III or IV)
  • Left ventricular systolic dysfunction (LVEF ≤ 35%)
  • Sinus rhythm and resting heart rate ≥ 70 bpm
  • Optimal and unchanged CHF medications or dosages

Exclusion Criteria:

  • Unstable condition within previous 4 weeks
  • Myocardial infarction or coronary revascularisation within previous 2 months
  • Stroke or transient cerebral ischaemia within previous 4 weeks
  • Congenital heart disease
  • Severe valvular disease
  • Active myocarditis
  • Permanent atrial fibrillation or flutter
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): NCT02441218


Locations
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France
Hôpital Pitié-Salpétrière
Paris, France, 75013
Sweden
Göteborg University
Göteborg, Sweden, S 41685
Sponsors and Collaborators
Institut de Recherches Internationales Servier
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT02441218    
Other Study ID Numbers: CL3-16257-063
2006-000708-18 ( EudraCT Number )
First Posted: May 12, 2015    Key Record Dates
Results First Posted: June 29, 2015
Last Update Posted: January 3, 2020
Last Verified: January 2020
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