Immune activation in chronic heart failure and the role of endotoxin
| ISRCTN | ISRCTN21486547 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21486547 |
| Protocol serial number | N0201082084 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Royal Brompton and Harefield NHS Trust (UK) Joint Committee for Research |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/02/2020
- 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
Contact information
Prof Philip A Poole-Wilson
Scientific
Scientific
Imperial College School of Medicine NHLI
Guy Scadding Building
Dovehouse Street
London
SW3 6LY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Immune activation in chronic heart failure and the role of endotoxin |
| Study objectives | To investigate whether CHF is associated with immune dysregulation and to establish whether endotoxin levels are increased in heart failure patients and whether an endotoxin challenge is a component of immune activation in patients with severe CHF. Study could lead to new therapeutic insights and could contribute to the development of new therapeutic strategies for immune activation in CHF and a syndrome currently without effective treatment ie cardiac cachexia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Chronic heart failure |
| Intervention | Study A: Randomised Controlled Trial (10 cachetic and 10 non-cachetic stable CHF patients, and 10 controls) Study B: Cohort Observation (10 CHF patients presenting acute oedematous exacerbation) |
| Intervention type | Other |
| Primary outcome measure(s) | Not provided at time of registration |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 29/06/2006 |
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 | 01/04/1997 |
| Date of final enrolment | 29/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Imperial College School of Medicine NHLI
London
SW3 6LY
United Kingdom
SW3 6LY
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? |
|---|---|---|---|---|---|
| Results article | results | 29/05/1999 | 28/02/2020 | Yes | No |
Editorial Notes
28/02/2020: Publication reference added.
