Evaluation of the anti-arrhythmic effects of 3 dosages of S 44121 versus placebo in patients with chronic heart failure at risk for ventricular arrhythmia
| ISRCTN | ISRCTN14227980 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14227980 |
| EudraCT/CTIS number | 2009-014940-12 |
| Secondary identifying numbers | CL2-44121-006 |
- Submission date
- 27/04/2010
- Registration date
- 21/05/2010
- Last edited
- 20/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof J Camm
Scientific
Scientific
St. Georges' University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
Study information
| Study design | Randomised double-blind parallel-group placebo-controlled international multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of the anti-arrhythmic effects of 3 oral dosages of S 44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia: a 12-week, randomised, double-blind, parallel-group, placebo controlled, international multicentre study |
| Study objectives | To evaluate the anti-arrhythmic efficacy of S 44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction for prevention of ventricular arrhythmia. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Cardiac arrhythmia in chronic heart failure |
| Intervention | A 2-week run-in period followed by 12-week randomised double-blind period of S 44121 versus placebo, and a 2-week follow-up period. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | S 44121 |
| Primary outcome measure | Efficacy measurements recorded on the Holter ECG, measured at at inclusion visit and 1 week, 4 weeks and 12 weeks of treatment |
| Secondary outcome measures | 1. Safety profile measured by 12-lead resting ECG, measured at each visit 2. Physical examination, measured at each visit 3. Adverse events, recorded throughout the study 4. Blood clinical laboratory parameters, measured at at inclusion visit and after 12 weeks of treatment |
| Overall study start date | 01/03/2010 |
| Completion date | 28/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Total final enrolment | 149 |
| Key inclusion criteria | 1. Both genders patients between 18 years or legal age and 80 years 2. Symptomatic chronic heart failure for at least 6 months 3. Ischaemic disease or idiopathic dilated cardiomyopathy as main cause for chronic heart failure |
| Key exclusion criteria | 1. Women who are pregnant, breast-feeding or not using contraception 2. Recent myocardial infarction, unstable angina or coronary revascularisation less than 3 months before selection 3. History of stroke or cerebral transient ischemic attack within the previous 3 months before selection |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 28/02/2013 |
Locations
Countries of recruitment
- Argentina
- Australia
- Belgium
- Canada
- Czech Republic
- England
- France
- Germany
- Hungary
- Korea, South
- Netherlands
- Poland
- Portugal
- Singapore
- Slovakia
- Spain
- Taiwan
- United Kingdom
Study participating centre
St. Georges' University of London
London
SW17 0RE
United Kingdom
SW17 0RE
United Kingdom
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | 20/04/2020 | No | No |
Editorial Notes
20/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
23/11/2018: Link to basic results added.
30/09/2016: Internal review
29/11/2012: The following changes were made to the record:
1. Argentina, Belgium, Netherlands, Taiwan, Korea and Singapore were added to the countries of recruitment.
2. The overall trial end date was changed from 31/12/2011 to 28/02/2013.
15/03/2011: The overall trial end date was changed from 31/07/2011 to 31/12/2011.
