Condition category
Circulatory System
Date applied
25/07/2006
Date assigned
14/08/2006
Last edited
15/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Karl Swedberg

ORCID ID

Contact details

Göteborg University
Heart and Lung Institute
Department of Medicine
Sahlgrenska
University Hospital/Östra
Göteborg
S 416 85
Sweden

Additional identifiers

EudraCT number

2006-000708-18

ClinicalTrials.gov number

Protocol/serial number

CL3-16257-063

Study information

Scientific title

Effects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction: a three-year randomised double-blind placebo-controlled international multicentre study

Acronym

SHIFT

Study hypothesis

Demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality and hospitalisations for worsening heart failure.

Ethics approval

First French Ethics Committee approval obtained on 06/06/2006 from the CCPPRB Ambroise Paré (dossier: 06 06 46).

Study design

Double-blind randomised placebo-controlled two parallel and balanced treatment arms study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic heart failure

Intervention

S16257 tablets containing 2.5 or 5 or 7.5 mg of ivabradine versus matching placebos.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ivabradine

Primary outcome measures

Composite endpoint made of cardiovascular mortality or hospitalisation for worsening heart failure

Secondary outcome measures

Composite and non-composite endpoints including all deaths and all hospitalisations, change in functional capacity and clinical symptoms of heart failure

Overall trial start date

15/09/2006

Overall trial end date

30/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female aged more than 18 years
2. Chronic heart failure
3. Left ventricular systolic dysfunction
4. Sinus rhythm

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6500

Participant exclusion criteria

1. Unstable cardiovascular condition
2. Recent myocardial infarction or coronary revascularisation
3. Congenital heart disease
4. Severe valvular disease
5. Active myocarditis

Recruitment start date

15/09/2006

Recruitment end date

30/04/2010

Locations

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Korea, South, Latvia, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Turkey, Ukraine, United Kingdom

Trial participating centre

Göteborg University
Göteborg
S 416 85
Sweden

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19892778
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20801500
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22617188
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23933545
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26873681

Publication citations

  1. Protocol

    Swedberg K, Komajda M, Böhm M, Borer JS, Ford I, Tavazzi L, Rationale and design of a randomized, double-blind, placebo-controlled outcome trial of ivabradine in chronic heart failure: the Systolic Heart Failure Treatment with the I(f) Inhibitor Ivabradine Trial (SHIFT)., Eur. J. Heart Fail., 2010, 12, 1, 75-81, doi: 10.1093/eurjhf/hfp154.

  2. Results

    Swedberg K, Komajda M, Böhm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L, , Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study., Lancet, 2010, 376, 9744, 875-885, doi: 10.1016/S0140-6736(10)61198-1.

  3. Results

    Swedberg K, Komajda M, Böhm M, Borer J, Robertson M, Tavazzi L, Ford I, , Effects on outcomes of heart rate reduction by ivabradine in patients with congestive heart failure: is there an influence of beta-blocker dose?: findings from the SHIFT (Systolic Heart failure treatment with the I(f) inhibitor ivabradine Trial) study., J. Am. Coll. Cardiol., 2012, 59, 22, 1938-1945, doi: 10.1016/j.jacc.2012.01.020.

  4. Results

    Reil JC, Tardif JC, Ford I, Lloyd SM, O'Meara E, Komajda M, Borer JS, Tavazzi L, Swedberg K, Böhm M, Selective heart rate reduction with ivabradine unloads the left ventricle in heart failure patients., J. Am. Coll. Cardiol., 2013, 62, 21, 1977-1985, doi: 10.1016/j.jacc.2013.07.027.

  5. Results

    Böhm M, Robertson M, Borer J, Ford I, Komajda M, Mahfoud F, Ewen S, Swedberg K, Tavazzi L, Effect of Visit-to-Visit Variation of Heart Rate and Systolic Blood Pressure on Outcomes in Chronic Systolic Heart Failure: Results From the Systolic Heart Failure Treatment With the If Inhibitor Ivabradine Trial (SHIFT) Trial, J Am Heart Assoc, 2016, 5, 2, e002160, doi: 10.1161/JAHA.115.002160.

Additional files

Editorial Notes

15/02/2016: Publication reference added. On 29/11/2012 the following changes were made to the trial record: 1. The target number of participants was changed from 5500 to 6500. 2. The overall trial end date was changed from 15/09/2009 to 30/04/2010.