A single centre, placebo controlled trial to investigate the safety and tolerability of bisoprolol in patients with chronic heart failure and chronic obstructive pulmonary disease
| ISRCTN | ISRCTN20367656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20367656 |
| Protocol serial number | N0192107572 |
| Sponsor | Department of Health (UK) |
| Funder | Nottingham University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 13/10/2017
- 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
Cardovascular Medicine
D Floor, South Block
University Hospital
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 single centre, placebo controlled trial to investigate the safety and tolerability of bisoprolol in patients with chronic heart failure and chronic obstructive pulmonary disease |
| Study objectives | 1. Is bisoprolol safe and well tolerated in patients with heart failure and chronic obstructive pulmonary disease? 2. What effects does bisoprolol have on neurohormones in patients with heart failure? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Heart failure |
| Intervention | Randomised controlled trial. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | bisoprolol |
| Primary outcome measure(s) |
1. a significant deterioration in spirometry (forced expiratory volume in one second [FEV1]) measurements |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/08/2004 |
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 meet inclusion criteria |
| Date of first enrolment | 17/05/2003 |
| Date of final enrolment | 30/08/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cardovascular Medicine
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 |
Editorial Notes
13/10/2017: No publications found, study status unverified
