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 |
| Clinical Trials Information System (CTIS) | 2009-014940-12 |
| Protocol serial number | CL2-44121-006 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
St. Georges' University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind parallel-group placebo-controlled international multicentre study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | S 44121 |
| Primary outcome measure(s) |
Efficacy measurements recorded on the Holter ECG, measured at at inclusion visit and 1 week, 4 weeks and 12 weeks of treatment |
| Key secondary outcome measure(s) |
1. Safety profile measured by 12-lead resting ECG, measured at each visit |
| Completion date | 28/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
- Argentina
- Australia
- Belgium
- Canada
- Czech Republic
- France
- Germany
- Hungary
- Korea, South
- Netherlands
- Poland
- Portugal
- Singapore
- Slovakia
- Spain
- Taiwan
Study participating centre
SW17 0RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
