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 |
| Secondary identifying numbers | N0192107572 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | bisoprolol |
| Primary outcome measure | 1. a significant deterioration in spirometry (forced expiratory volume in one second [FEV1]) measurements 2. the levels of several neurohormones in heart failure patient's blood |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 17/05/2003 |
| Completion date | 30/08/2004 |
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 meet inclusion criteria |
| Date of first enrolment | 17/05/2003 |
| Date of final enrolment | 30/08/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardovascular Medicine
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 |
Editorial Notes
13/10/2017: No publications found, study status unverified
