Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0203157787
Study information
Scientific title
Acronym
Study hypothesis
What is the effect of treatment with the antihypertensive agents lisinopril and labetalol on baroreflex sensitivity (BRS) in patients with previous stroke or transient ischaemic attack (TIA)?
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular: Stroke
Intervention
Our hypothesis is that treatment with the antihypertensive agents lisinopril and labetalol produces an improvement in baroreflex sensitivity in stroke patients.
All patients seen on the rapid access stroke clinic or discharged home from the acute stroke unit with a diagnosis of stroke in whom the physician responsible for their care considers antihypertensive agents are indicated will be considered for this study. If they fulfill the inclusion criteria, have none of the exclusion criteria and give consent then they are entered into the trial.
Participants will receive lisinopril and labetalol consecutively in a randomly allocated order with a 2 week washout period between each treatment. The dose of each drug will be carefully titrated up until the desired response in blood pressure is seen (a fall in systolic blood pressure of 10mmHg). Periods of monitoring will be conducted immediately prior to each treatment and after they have been on their target dose for 14 days.
A flow chart summarising what will happen to each participant is included at the end of the study protocol.
The period of monitoring will involve initially 2 periods of casual blood pressure (BP) monitoring (3 readings repeated 10 minutes apart). Participants will then undergo recording of beat-to-beat blood pressure monitoring, using the Portapres non-invasive BP recording device. This involves the application of an inflatable cuff to the finger, which can cause some tingling, but should not cause any discomfort. At the same time, an ECG monitor is attached, and respiratory frequency is measured by means of an abdominal wasteband. 3 sequential readings are taken using this equipment, and analysis of this data using spectral and sequence analysis methods provides an estimate of BRS. Participants will also have recordings of central arterial stiffness performed using applanation tonometry to obtain information on arterial waveforms and pulse wave velocity. This is a non-invasive technique which involves the application of a probe over the radial artery at the wrist, the carotid artery in the neck, and the femoral artery in the groin (although there will be no need to remove undergarments). This period of monitoring should take approximately one hour.
Each participant will also have the following data collected: The severity of their stroke (using the NIH stroke scale), stroke classification, side of the lesion, neuroimaging findings, presence of carotid artery disease, vascular risk factors and past vascular events.
Throughout the study, participants will be monitored for side effects related to their trial medication such as symptomatic bradycardia or hypotension. Blood tests will also be taken prior to commencing treatment and after 1 week to check for any deterioration in renal function. If any side effects occur, the treatment will be withdrawn.
In view of the scientific nature of the studies, their designs have been guided by perceived gaps in current medical literature, rather than direct user involvement. However, a detailed patient information leaflet, and an opportunity to ask questions, will be provided.
The methods used for obtaining BRS and arterial compliance information have been used extensively in other trials, in both stroke patients, and other clinical conditions.
Intervention type
Drug
Phase
Not Specified
Drug names
lisinopril, labetalol
Primary outcome measure
Change in BRS seen as a result of treatment with lisinopril and labetalol.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
07/01/2005
Overall trial end date
31/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with previous stroke or transient ischaemic attack (TIA).
1. Age > 18 years
2. Clinical diagnosis of stroke > 8 weeks ago
3. Stable neurology
4. Clinical indication for antihypertensive treatment
5. Informed consent
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
23 participants, no control group
Participant exclusion criteria
1. Excessive ectopic activity
2. Atrial fibrillation
3. Contraindication to beta blocker therapy
4. Contraindication to ace inhibitor therapy
5. Clinical indication for treatment with ace inhibitor, beta blocker or angiotesin II antagonist other than hypertension
6. Conditions independently associated with autoimmune dysfunction (acute myocardial infarction, unstable angina, active heart failure, diabetes mellitus)
Recruitment start date
07/01/2005
Recruitment end date
31/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2005 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Devon & Exeter NHS Foundation Trust (NHS R&D Support Funding)
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
Basic results (scientific)
Publication list