Thalidomide for chronic heart failure
| ISRCTN | ISRCTN44663253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44663253 |
| Protocol serial number | N0084089156 |
| Sponsor | Department of Health (UK) |
| Funder | The North and South Bank Research and Development Consortium (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Thalidomide |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Cardiology
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
HU16 5JQ
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 |
