Effects of ivabradine on cardiovascular events in patients with moderate to severe chronic heart failure and left ventricular systolic dysfunction
| ISRCTN | ISRCTN70429960 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70429960 |
| Clinical Trials Information System (CTIS) | 2006-000708-18 |
| Protocol serial number | CL3-16257-063 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 25/07/2006
- Registration date
- 14/08/2006
- Last edited
- 26/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
Göteborg University
Heart and Lung Institute
Department of Medicine
Sahlgrenska
University Hospital/Östra
Göteborg
S 416 85
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised placebo-controlled two parallel and balanced treatment arms study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | SHIFT |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Ivabradine |
| Primary outcome measure(s) |
Composite endpoint made of cardiovascular mortality or hospitalisation for worsening heart failure |
| Key secondary outcome measure(s) |
Composite and non-composite endpoints including all deaths and all hospitalisations, change in functional capacity and clinical symptoms of heart failure |
| Completion date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 6500 |
| Key inclusion criteria | 1. Male or female aged more than 18 years 2. Chronic heart failure 3. Left ventricular systolic dysfunction 4. Sinus rhythm |
| Key exclusion criteria | 1. Unstable cardiovascular condition 2. Recent myocardial infarction or coronary revascularisation 3. Congenital heart disease 4. Severe valvular disease 5. Active myocarditis |
| Date of first enrolment | 15/09/2006 |
| Date of final enrolment | 30/04/2010 |
Locations
Countries of recruitment
- United Kingdom
- 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
- Türkiye
- Ukraine
Study participating centre
S 416 85
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/09/2010 | Yes | No | |
| Results article | results | 11/09/2010 | Yes | No | |
| Results article | results | 29/05/2012 | Yes | No | |
| Results article | results | 19/11/2013 | Yes | No | |
| Results article | results | 12/02/2016 | Yes | No | |
| Results article | results | 24/03/2017 | Yes | No | |
| Results article | results | 01/07/2020 | 26/06/2020 | Yes | No |
| Protocol article | protocol | 01/01/2010 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/06/2020: Publication reference added.
28/03/2018: Amended publication plan and IPD statement.
24/01/2018: Publication plan and IPD sharing statement added.
11/12/2017: results summary and publication reference added.
21/03/2017: Publication reference added.
15/02/2016: Publication reference added.
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.
