Aleskiren Effect on Plaque Progression Using 3-dimensional Magnetic Resonance Imaging (3D MRI)

2014-08-27 03:13:40 | BioPortfolio


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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment




Aliskiren, placebo


OSU Davis Heart and Lung Research Institute
United States




Ohio State University

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:40-0400

Clinical Trials [392 Associated Clinical Trials listed on BioPortfolio]

Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet

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.

Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients

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...

Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone

Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

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...

Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

PubMed Articles [1682 Associated PubMed Articles listed on BioPortfolio]

Effect of aliskiren, a direct renin inhibitor, on the protective action of antiepileptic drugs against pentylenetetrazole-induced clonic seizures in mice.

It has been demonstrated that certain angiotensin-converting enzyme (ACE) inhibitors and angiotensin AT receptor antagonists can possess anticonvulsant activity. The purpose of the current study was t...

Aliskiren: Preclinical evidence for the treatment of hyperproliferative skin disorders.

Psoriasis is a complex inflammatory and hyperproliferative skin disease. The pathogenesis and mechanisms involved are not completely understood, which makes treatment a difficult issue. Angiotensin II...

Characterization of solution stress degradation products of aliskiren and prediction of their physicochemical and ADMET properties.

Forced degradation studies on aliskiren were carried out according to ICH and WHO guidelines. Six degradation products were formed in total in the solution state. Their separation among themselves and...

Matrix metalloproteinase-10 deficiency delays atherosclerosis progression and plaque calcification.

Matrix metalloproteinases (MMPs) have been implicated in atherosclerosis and vascular calcification. Among them, we reported that MMP10 is present in human atheroma, associated with atherosclerosis. H...

Progranulin in the hematopoietic compartment protects mice from atherosclerosis.

Progranulin is a circulating protein that modulates inflammation and is found in atherosclerotic lesions. Here we determined whether inflammatory cell-derived progranulin impacts atherosclerosis devel...

Medical and Biotech [MESH] Definitions

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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