Aliskiren vs Hydrochlorothiazide in Hypertensive Type II Diabetic Patients on Resistance Arteries
Status:
Withdrawn
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
This study will be performed only at the Jewish General Hospital. It will investigate the
effect of treatment with aliskiren, an inhibitor of renin, a substance produced by the kidney
that constricts arteries and raises blood pressure, on the blood vessels, specifically the
arteries, of subjects who have diabetes and elevated blood pressure (hypertension).
To investigate blood vessels, different techniques will be used. For large arteries, these
will be studied by non invasive methods using detection of the pulse wave or using ultrasound
over the skin of the neck, the wrist and the groin. To study small vessels, the investigators
will perform a biopsy on the buttock, under local anesthesia, and obtain a small sample of
tissue from under the skin, from which the vessels will be dissected. The investigators have
performed many hundreds of these small biopsies over the past 20 years for similar studies
without any complications. The biopsies are very well tolerated. From this research the
investigators will thus be able to learn what the structure and function of these vessels is
in these patients, in comparison to a normal healthy group.
The hypertensive diabetic subjects will then be assigned by chance (randomized trial) to
treatment with the renin inhibitor aliskiren or a comparator, the diuretic
hydrochlorothiazide. Aliskiren is a relatively new drug used to treat hypertension that is
very well tolerated and is now being evaluated in numerous trials in hypertensive diabetic
individuals. The diuretic is a well-know agent used to treat high blood pressure now for many
years, and which is very well tolerated. Physicians, nurses and scientists involved in the
study will be unaware of who is receiving which drug, as will be the patients (this is the
meaning of double-blind trial). However, if there is any problem, the secret code will be
broken and the individual withdrawn from the study. Subjects will be treated for a year, and
the study procedures (non invasive and the biopsy) repeated at 6 months and after one year of
treatment. During the study, blood samples will be drawn and urine collected at certain
intervals to ensure safety of the treatment.
Once tissues are obtained they will be studied in the laboratory. The study of the vessels
will allow treatment us to determine how the treatment with the renin inhibitor aliskiren
affects the structure and function as well as cellular and molecular aspects of arteries of
hypertensive diabetic persons. The investigators expect these studies to provide us knowledge
on mechanisms and perhaps new targets for future therapies of cardiovascular disease and
hypertension.