A randomised cross-over study comparing the effectiveness of bisoprolol and lisinopril in controlling hypertension after liver transplantation
| ISRCTN | ISRCTN19063620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19063620 |
| Secondary identifying numbers | N0544093459 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 21/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Graeme JM Alexander
Scientific
Scientific
Box No 157
Department of Medicine
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Bisoprolol versus lisinopril for hypertension after liver transplantation |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 27/06/2000 |
| Completion date | 27/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key inclusion criteria | 40 Patients over 18 undergoing outpatient follow-up and having persisting hypertension. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 27/06/2000 |
| Date of final enrolment | 27/06/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box No 157
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Other
Cambridge Consortium - Addenbrookes (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/03/2004 | Yes | No |
