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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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 objectives1. 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) studiedCardiovascular: Heart failure
InterventionRandomised controlled trial.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)bisoprolol
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date17/05/2003
Completion date30/08/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants20
Key inclusion criteriaTotal number of subjects = 20.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment17/05/2003
Date of final enrolment30/08/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Cardovascular Medicine
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Department of Health (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

13/10/2017: No publications found, study status unverified