A pilot study to assess the effect of beta blockade on exercise capacity and BNP levels in patients with predominantly diastolic heart failure
| ISRCTN | ISRCTN77645264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77645264 |
| Protocol serial number | N0226167747 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | South Manchester University Hospitals NHS Trust, South Manchester University Hospitals NHS Trust, NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/10/2016
- 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 Nicholas Brooks
Scientific
Scientific
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 2751/ 2752/ 2743 |
|---|---|
| nicholas.brooks@smtr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A pilot study to assess the effect of beta blockade on exercise capacity and BNP levels in patients with predominantly diastolic heart failure |
| Study objectives | Does the use of beta-blockers in patients with diastolic dysfunction and preserved systolic function result in a significant improvement in quality of life and exercise capacity, a significant reduction in plasma BNP levels, and improved CRP and interleukin levels? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Heart failure |
| Intervention | 1. Bisoprolol (1.25 mg daily) 2. Placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bisoprolol |
| Primary outcome measure(s) |
The change from baseline in plasma BNP measurements |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 19/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | A total of 40 patients with evidence or history of clinical heart failure, ejection fraction of >45% and raised plasma BNP levels. |
| Key exclusion criteria | 1. History of asthma / COPD 2. Hypotension, patients with significant bradycardia 3. BMI>30 4. Intolerant of beta-blockers, patients with constrictive pericarditis, with severe peripheral vascular disease, patients having suffered myocardial infarction within 3 months prior to enrolment 5. Pregnant women 6. Use of any investigational drug within 2 weeks of enrolment 7. Any recent changes in cardiac medications |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 19/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom
M23 9LT
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 |
Editorial Notes
28/10/2016: No publications found, verifying study status with principal investigator
