Thalidomide for chronic heart failure
| ISRCTN | ISRCTN44663253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44663253 |
| Secondary identifying numbers | N0084089156 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 01/11/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew Clark
Scientific
Scientific
Department of Cardiology
Castle Hill Hospital
Castle Road
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
| Phone | +44 (0)1482 875 875 |
|---|---|
| A.L.Clark@hull.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is thalidomide a benefit to patients with chronic heart failure, specifically those with evidence of cachexia? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Heart failure |
| Intervention | Randomised controlled trial comparing a) thalidomide and b) placebo 100 mg twice daily for 12 weeks in random order. End points will be measured at baseline, crossover point and end of study. Added 27/09/2013: this trial was stopped due to poor recruitment in 2004. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Thalidomide |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2000 |
| Completion date | 01/12/2008 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2000 |
| Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Cardiology
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Research organisation
The North and South Bank Research and Development Consortium (UK)
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 |
