Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
21/07/2009
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 Graeme JM Alexander

ORCID ID

Contact details

Box No 157
Department of Medicine
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544093459

Study information

Scientific title

Acronym

Study hypothesis

Bisoprolol versus lisinopril for hypertension after liver transplantation

Ethics approval

Not provided at time of registration

Study design

Randomised controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular: Hypertension

Intervention

Hypertension is common after liver transplantation and in Cambridge occurs in approximately 75% of patients. Treatment generally involves more than one drug but there have not been any studies comparing different antihypertensive medication. Thus optimal treatment of hypertension is not known. A cross-over study is planned to compare bisoprolol with lisinopril in patients with sustained hypertension after transplantation. Our current practice is to commence patients on amlodipine for hypertension. If this fails to control blood pressure then the dose is increased and patients are also commenced on a statin drug such as cerivastatin. Patients whose blood pressure is not controlled with amlodipine will then be randomised to receive either bisoprolol or lisinopril for 3 months, after which those taking bisoprolol will change to lisinopril and vice versa for a further 3 months. At this point the study ceases and the two treatments will be compared. Patients will be reviewed monthly in clinic to assess response to treatment and to allow for dosage adjustment where necessary. Measurements of plasma renin and arterial stiffness, using an ultrasound machine, will be collected during the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

27/06/2000

Overall trial end date

27/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

40 Patients over 18 undergoing outpatient follow-up and having persisting hypertension.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

27/06/2000

Recruitment end date

27/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 157
Cambridge
CB2 2QQ
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

Other

Funder name

Cambridge Consortium - Addenbrookes (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

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15021839

Publication citations

  1. Results

    Neal DA, Brown MJ, Wilkinson IB, Byrne CD, Alexander GJ, Hemodynamic effects of amlodipine, bisoprolol, and lisinopril in hypertensive patients after liver transplantation., Transplantation, 2004, 77, 5, 748-750.

Additional files

Editorial Notes