A randomised double blind placebo controlled trial of the addition of metformin to optimal treatment in patients with chronic heart failure. Assessment by regional haemodynamics neurohumoral activation and symptomatic well being
| ISRCTN | ISRCTN22334267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22334267 |
| Secondary identifying numbers | N0192080686 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 AJ Cowley
Scientific
Scientific
Department of Cardiovascular Medicine
D Floor South Block
Nottingham
NG7 2UH
United Kingdom
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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised double blind placebo controlled trial of the addition of metformin to optimal treatment in patients with chronic heart failure. Assessment by regional haemodynamics neurohumoral activation and symptomatic well being |
| Study objectives | To determine whether metformin is of benefit in the treatment of patients with congestive heart failure. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Congestive heart failure (CHF) |
| Intervention | Randomised controlled trial. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure | 1. Regional haemodynamics 2. Neurohumoral 3. Symptomatic well being |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 15/02/2000 |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | Total number of subjects = 20 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 15/02/2000 |
| Date of final enrolment | 31/08/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
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
Hospital/treatment centre
Nottingham University Hospitals NHS Trust (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 |
