| log-in | software
INVITATION TO TAKE PART IN RESEARCH INTO
THE INHERITANCE OF HIGH BLOOD PRESSURE (HYPERTENSION)
are being invited to take part in research investigating how
high blood pressure runs in families. Before you decide, it
is important that you understand why this research is being
done and what this involves. Please take time to read the following
information carefully and discuss it with a friend, relative
and your GP, if you wish. Be sure to ask any questions you may
have, especially if anything is unclear, or you would like to
know more. Take time to decide, whether or not you wish to take
part. Thank you for reading this information.
What are we aiming to do?
In co-operation with other doctors and scientists throughout
the country we are studying the inherited factors (genes), which
lead people to develop high blood pressure. By understanding
which genes cause this problem, it may be possible to improve
the treatment to prevent strokes and heart attacks. We aim to
recruit 1000 families over a period of 18 months. These families
will be comprised of two parents, who may or may not have high
blood pressure, and one affected son or daughter. At the end
of the study we aim to have a total of 3000 people involved.
Why are we seeking your help?
Recently, you or one of your relatives returned a questionnaire
on your family history of high blood pressure. Based upon this
information and questions you have allowed us to ask your family
doctor, about your blood pressure, we are now inviting you and
other members of your immediate family, to help us further with
this research. We will not ask you to take part if you have
diabetes, kidney disease, anaemia or receive blood transfusions,
or are under treatment for cancer. If you are uncertain if you
should take part please ask us. Having read this information
sheet and listened to one of our trained nurses explain the
study, you are under no obligation to continue taking part.
Your participation in any aspect of the study is completely
up to you. You are under no obligation to provide us with any
information you do not wish to divulge.
blood stream white cells which normally fight infection carry
a complete set of your genes which we can study. We would like
to store some of these white cells in the laboratory because
we think it will take many years and a lot of experiments to
understand the cause of high blood pressure. Please note;
- No information
about you or your genes will be released to anyone at anytime
in a form by which they could identify you. Personal details
about you and your health record will be stored in a computer
but not in a form by which anyone could identify you.
genes will be used to investigate the inherited cause of high
blood pressure and related diseases such as stroke. It is
possible that this research will lead to the development of
new treatments for high blood pressure. Neither you or the
researchers involved in this study will benefit financially
from this research.
- We cannot
guarantee to discover anything that will directly benefit
you or your family.
- We will
be happy to transmit any concerns or questions regarding your
treatment to your GP but, we will not offer advice regarding
treatment and will not adjust your treatment.
What will we be asking you to do?
counselling, we will ask you to donate a 70 ml blood sample
(less than half a tea cupful) which will be taken by needle
and syringe from a blood vessel in your arm. This should only
cause a brief discomfort. The sample will be used to obtain
a set of your genes from the white cells and to make other routine
tests which we would usually do as part of the investigation
of a patient with high blood pressure. This will include a heart
tracing (ECG) and measurement of your blood pressure over 24
hours which can be recorded automatically by a machine the size
of a personal stereo which you wear attached to a belt. The
machine does make a slight noise when it inflates the cuff and
people who find the inflation of the cuff uncomfortable when
they have their blood pressure taken at their surgery may notice
slight discomfort. We will measure your height, weight, waist
and hip size and measure the thickness of the skin on your arms.
In addition we will ask you to collect all your urine for 24
hours in a special
bottle which we will provide. Finally, if you are able to attend
the hospital, we would like to organise an echocardiogram (this
is a measure of heart muscle size using sound waves), which
will give us useful information about how your blood pressure
affects you. This information will help your own doctor decide
if your blood pressure treatment is being effective, and is
often part of the routine care of patients with high blood pressure.
provide your doctor with a copy of your 24 hour blood pressure
record and any other information which may help in your care.
In total you will receive 2-3 phone calls and be asked to meet
with 1 of our trained nurses once or twice. Travel expenses
will be reimbursed. Once we have identified enough families
we will start to search for the genes which lead to high blood
pressure. You are welcome to phone us on 0207 882 3422 (3425
/ 3424) to check on our progress and we will be in touch to
update you. If you have any questions please do ask at any stage.
You are free not to participate and may withdraw from the study
at any time. This will not affect your medical treatment
OF RESEARCH PROPOSAL: AN INVESTIGATION OF THE GENETIC BASIS
OF HUMAN ESSENTIAL HYPERTENSION BY GENOME WIDE SEARCH.
I have read
the attached information on the above research project and have
been given a copy to keep.
I have had the opportunity to discuss the details and ask questions
about this information and the Investigator has explained the
nature and purpose of the research and I understand what is
proposed. I understand that this study is part of a research
project designed to promote medical knowledge.
I have been
informed that the proposed study involves monitoring and special
examinations which have been explained to me, together with
possible risk involved. I understand that my personal involvement
and any results will remain strictly confidential.
I also understand
that my General Practitioner will be informed that I have taken
part in this study.
fully and freely consent to participate in this study.
PATIENT'S SIGNATURE ................................................................
PATIENT'S WITNESS' NAME: ......................................................................
WITNESS' SIGNATURE: .................................................................
INVESTIGATOR'S NAME: Dr Mark Caulfield
As the Clinician/Investigator responsible for this research
or a designated deputy, I confirm that I have explained to the
patient named above the nature and purpose of the research to
CLINICIAN'S NAME: DR MARK CAULFIELD
IF YOU ARE
AT ALL CONCERNED ABOUT THIS TRIAL PLEASE CONTACT:
Dr Mark Caulfield Tel. No. work 0207 882 3403
BY THE CONSULTANT OR PRINCIPAL INVESTIGATOR IN CHARGE OF PROPOSED
RESEARCH: E.C. NO.....
RESEARCH PROPOSAL: AN INVESTIGATION OF THE GENETIC BASIS OF
HUMAN ESSENTIAL HYPERTENSION BY GENOME WIDE SEARCH.