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

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. |
- 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.
- Cardiovascular Death [ Time Frame: From the date of randomization until the date of death, up to 42 months ]Component of the primary composite endpoint
- Hospitalisation for Worsening Heart Failure [ Time Frame: 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. ]
- Death From Heart Failure [ Time Frame: From the date of randomisation to death, up to 42 months. ]Component of cardiovascular death
- Hospitalisation for Any Cause [ Time Frame: 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 ]
- Unplanned Hospitalisation for Any Cause [ Time Frame: 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. ]
- 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

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

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
France | |
Hôpital Pitié-Salpétrière | |
Paris, France, 75013 | |
Sweden | |
Göteborg University | |
Göteborg, Sweden, S 41685 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
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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 |
Heart Failure Heart Diseases Cardiovascular Diseases |