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
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