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 |
| Protocol serial number | N0192080686 |
| Sponsor | Department of Health (UK) |
| Funder | Nottingham University Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure(s) |
1. Regional haemodynamics |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
