Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas Brooks

ORCID ID

Contact details

South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 2751/ 2752/ 2743
nicholas.brooks@smtr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226167747

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Cardiovascular: Heart failure

Intervention

1. Bisoprolol (1.25 mg daily)
2. Placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Bisoprolol

Primary outcome measures

The change from baseline in plasma BNP measurements

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2005

Overall trial end date

19/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

A total of 40 patients with evidence or history of clinical heart failure, ejection fraction of >45% and raised plasma BNP levels.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

19/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Manchester University Hospitals NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

South Manchester University Hospitals NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

28/10/2016: No publications found, verifying study status with principal investigator