Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/08/2015
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 AJ Cowley

ORCID ID

Contact details

Cardovascular Medicine
D Floor
South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192107572

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular: Heart failure

Intervention

Randomised controlled trial.

Intervention type

Drug

Phase

Not Specified

Drug names

bisoprolol

Primary outcome measures

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 trial start date

17/05/2003

Overall trial end date

30/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Total number of subjects = 20.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

17/05/2003

Recruitment end date

30/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardovascular Medicine
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Nottingham University Hospitals NHS Trust (UK)

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