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)

January 2, 2020 updated by: Institut de Recherches Internationales Servier
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6505

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Hôpital Pitié-Salpêtrière
  • Sweden
      • Göteborg, Sweden, S 41685
        • Göteborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All over the study (up to 42 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Death
Time Frame: From the date of randomization until the date of death, up to 42 months
Component of the primary composite endpoint
From the date of randomization until the date of death, up to 42 months
Hospitalisation for Worsening Heart Failure
Time Frame: From the date of randomization to the date of first documented hospitalisation, up to 42 months
From the date of randomization to the date of first documented hospitalisation, up to 42 months
All-cause Mortality
Time Frame: From the date of randomisation to death, up to 42 months.
From the date of randomisation to death, up to 42 months.
Death From Heart Failure
Time Frame: From the date of randomisation to death, up to 42 months.
Component of cardiovascular death
From the date of randomisation to death, up to 42 months.
Hospitalisation for Any Cause
Time Frame: From the date of randomisation to the date of first documented hospitalisation, up to 42 months
From the date of randomisation to the date of first documented hospitalisation, up to 42 months
Hospitalisation for Cardiovascular Reason
Time Frame: From the date of randomisation to the first documented hospitalisation, up to 42 months
From the date of randomisation to the first documented hospitalisation, up to 42 months
Unplanned Hospitalisation for Any Cause
Time Frame: From the date of randomisation to the first documented hospitalisation, up to 42 months
From the date of randomisation to the first documented hospitalisation, up to 42 months
Unplanned Hospitalisation for CV Reason
Time Frame: From the date of randomisation to the first documented hospitalisation, up to 42 months.
From the date of randomisation to the first documented hospitalisation, up to 42 months.
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
From the date of randomisation to the date of the first event, up to 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Internationales Servier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL3-16257-063
  • 2006-000708-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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