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

Chronic Heart Failure Clinical Trial

— SHIFT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441218
• Other study ID #: CL3-16257-063
• Secondary ID: 2006-000708-18
• Status: Completed
• Phase: Phase 3
• Start date: September 2006
• Est. completion date: April 2010

Study information

• Verified date: January 2020
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6505
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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
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.

Locations

Country	Name	City	State
France	Hôpital Pitié-Salpétrière	Paris
Sweden	Göteborg University	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier

Countries where clinical trial is conducted

France,  Sweden, 

References & Publications (2)

Böhm M, Swedberg K, Komajda M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Heart rate as a risk factor in chronic heart failure (SHIFT): the association between heart rate and outcomes in a randomised placebo-controlled — View Citation

Swedberg K, Komajda M, Böhm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.	Number of patients having experienced the Primary Composite Endpoint.	All over the study (up to 42 months).
Secondary	Cardiovascular Death	Component of the primary composite endpoint	From the date of randomization until the date of death, up to 42 months
Secondary	Hospitalisation for Worsening Heart Failure		From the date of randomization to the date of first documented hospitalisation, up to 42 months
Secondary	All-cause Mortality		From the date of randomisation to death, up to 42 months.
Secondary	Death From Heart Failure	Component of cardiovascular death	From the date of randomisation to death, up to 42 months.
Secondary	Hospitalisation for Any Cause		From the date of randomisation to the date of first documented hospitalisation, up to 42 months
Secondary	Hospitalisation for Cardiovascular Reason		From the date of randomisation to the first documented hospitalisation, up to 42 months
Secondary	Unplanned Hospitalisation for Any Cause		From the date of randomisation to the first documented hospitalisation, up to 42 months
Secondary	Unplanned Hospitalisation for CV Reason		From the date of randomisation to the first documented hospitalisation, up to 42 months.
Secondary	Secondary Composite Endpoint	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

External Links

•   Results summary