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The reason for this study is to see if a drug called Aliskiren decreases the amount of plaque in the arteries of people who have health problems due to plaque, like heart disease or vascular disease. A 3-dimensional MRI is being used to examine plaque in the aorta (the large blood vessel coming out of the heart).
Epidemiologic and experimental data suggest that activation of renin-angiotensin system (RAS) has an important role in pathogenesis of atherosclerosis. Although ACE inhibitors and AT1R blockers have been used for more than a decade, their benefit in terms of absolute risk reduction is modest. Many patients with established atherosclerosis continue to suffer from recurrent events related to ongoing disease, despite inclusion of other evidence based approaches such as ASA and statin therapy. Tekturna is a new direct renin inhibitor that decreases plasma activity of AngII, which causes depression of the negative feedback of renin secretion from the kidney and results in no compensatory increase in plasma renin concentrations and prevents the formation of both AngI and AngII. This in turn results in effective antihypertensive effect in high blood pressure subjects. Moreover, there is direct experimental animal evidence to support aliskiren therapy as a mean to reduce atherosclerotic plaque progression in thoracic aorta.
This protocol is a pilot study exploring the effectiveness of direct renin inhibitor Aliskiren to reduce atherosclerotic plaque evolution as shown by 3D MRI quantification. The secondary objectives are to assess the change in % plaque volume; change in resting clinical systolic, diastolic and mean blood pressures and change in monocyte global gene expression.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
OSU Davis Heart and Lung Research Institute
Ohio State University
Published on BioPortfolio: 2014-08-27T03:13:40-0400
This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren.
The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard t...
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and...
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Lack of perfusion in the EXTREMITIES resulting from atherosclerosis. It is characterized by INTERMITTENT CLAUDICATION, and an ANKLE BRACHIAL INDEX of 0.9 or less.
Complete blockage of blood flow through one of the CORONARY ARTERIES, usually from CORONARY ATHEROSCLEROSIS.
A drug that has been given by mouth in the treatment of atherosclerosis and other vascular disorders, hyperlipidemias, and thrombo-embolic disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1408)
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