<<Local Headed Paper>>
GP Name and Address
Dear XXX,
Re:
Research study
PRESERVE: How intensively should we treat blood pressure in established
cerebral small vessel disease?
Study Participant: Name, Address and DOB
Your patient has agreed to enter the above research study.
This study is recruiting patients with cerebral small vessel disease. This disease is
increasingly common with age and results in stroke (lacunar stroke) as well as cognitive
impairment. This is a multi centre randomised controlled trial which is determining whether
intensive blood pressure lowering is more effective at reducing cognitive decline compared
with normal blood pressure lowering over a 2 year follow up period. The intensive blood
pressure lowering arm aims for a systolic blood pressure of less than 125mmHg. The
usual blood pressure lowering arm aims for a systolic blood pressure of 130 to 140mmHg,
as recommended by current guidelines. The trial is comparing 2 strategies for lowering
blood pressure and not looking at specific blood pressure drugs.
Your patient has been given a blood pressure monitor and will be contacted regularly by
the research team over the first few weeks until the blood pressure has reached the
required level after which they will be seen for regular follow ups as outlined in the enclosed
table. At each regular follow up they will receive a clinical assessment as well as cognitive
tests and blood pressure measurements. Some patients will also be entered in an MRI sub
study as part of which they will receive repeat MRI scans.
We will inform you about any changes in blood pressure medication. This is an important
clinical question and we would be very grateful for your support in carrying out this study
and supporting achieving the required blood pressure level for your patient.
If you have any questions at any time please do not hesitate to contact us on the contact
details given.
With many thanks for your support and best wishes.
Yours sincerely,
Local PI
Enc. Treatment Allocation and Schedule of Procedures
GP Letter Version 2 23 Jan 2012
Treatment Allocation:
Your patient Insert patient name has been allocated to:
Standard blood pressure lowering
Intensive blood pressure lowering
Your patient is involved in an MRI sub study:
Yes
No
Study procedures:
Visit
Screening
Baseline
Procedures
/
 Clinical examination, review of history and brain scan to ensure
eligibility, informed consent.
 BP Reading
 Review of medication
 Cognitive assessment
 Disability and quality of life questionnaires
 MRI (only if in substudy)
1 month follow up
 BP Reading
 Review of medication
3 month follow up




6 month follow up
 BP Reading
 Review of medication
12 month follow up




18 month follow up
 BP Reading
 Review of medication
24 month follow up





BP Reading
Review of medication
Cognitive assessment
MRI (only if in substudy)
BP Reading
Review of medication
Cognitive assessment
Disability and quality of life questionnaires
BP Reading
Review of medication
Cognitive assessment
Disability and quality of life questionnaires
MRI (only if in substudy)
GP Letter Version 2 23 Jan 2012