Effects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction

Plain English Summary

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

Study website

Type

Scientific

Contact name

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

EudraCT/CTIS number

2006-000708-18

IRAS number

ClinicalTrials.gov number

Protocol/serial number

CL3-16257-063

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(s)

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

Study setting(s)

Other

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details 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

Pharmaceutical study type(s)

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

Ivabradine

Primary outcome measure

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 study start date

15/09/2006

Overall study end date

30/04/2010

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

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

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

Study participating centre

Göteborg University
Göteborg
S 416 85
Sweden

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

ROR

https://ror.org/034e7c066

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Publication plan:
Summary results are published on https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.

Intention to publish date

Individual participant data (IPD) sharing plan

The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.

IPD sharing plan summary

Available on request

Study outputs