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ISRCTN
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ISRCTN19063620
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ClinicalTrials.gov identifier
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Public title
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A randomised cross-over study comparing the effectiveness of bisoprolol and lisinopril in controlling hypertension after liver transplantation
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0544093459
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Study hypothesis
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Bisoprolol versus lisinopril for hypertension after liver transplantation
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled crossover trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular: Hypertension
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Participants - inclusion criteria
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40 Patients over 18 undergoing outpatient follow-up and having persisting hypertension.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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27/06/2000
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Anticipated end date
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27/06/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cambridge Consortium - Addenbrookes (UK)
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Trial website
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Publications
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2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15021839
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Contact name
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Dr
Graeme JM
Alexander
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Address
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Box No 157
Department of Medicine
Addenbrooke's NHS Trust
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)207 307 2622
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Fax
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+44 (0)207 307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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21/07/2009
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Date ISRCTN assigned
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12/09/2003
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