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<title><string language="fre"><![CDATA[Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval (FDA, and in EU, beyond CE mark) and reimbursement]]></string></title>
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<string language="fre"><![CDATA[Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval (FDA, and in EU, beyond CE mark) and reimbursement
Investigator viewpoint: George BAKRIS, Chicago, USA - Ileana PIÑA, New York, USA
Regulatory viewpoint: Andrew FARB, FDA, USA
Industry viewpoint: Rob KIEVAL, CVRx, USA - Kenneth STEIN, Boston Scientific, USA
Abstract : What are relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval and reimbursement What kind of evidence is needed and the level is somewhat clear. Obviously, data from prospective randomized trials such as SYMPLICITY HTN-1, 2 and 3 is level 1 evidence.  Additionally, there are two domains of answers: a). adequate response relative to a clinical endpoint of interest, and b). adequate relative to mechanism of either efferent and/ or afferent neurologic activity reduction. Ideally, both should be demonstrated, as the demonstration of either one of these does not assume the other has been proven. Obviously, efferent nerve measures, the “gold standard” being reduction of renal noradrenaline (NA) spillover or less accepted alternative would be alterations of renal vein renin production or angiotensin II. Direct measurements of renal sympathetic nerve activity are also possible. Afferent nerve measures are more complicated as reductions of MSNA and total body NA spillover can each be a consequence of reduced afferent nerve conduction and/or reduced ANGII influence on hypothalamic efferent activity. To meet approval clear evidence of blood pressure reduction of at least 10?15 mmHg needs to be achieved and sustained for at least six months. Follow-up of up to three years shows persistence of effect. Frankly, if the procedure provides a high likelihood of achieving a blood pressure target of]]></string></description>
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NOTE:BAKRIS George, Chicago, USA&lt;br&gt;George L. Bakris, MD, Hon. D, F.A.S.H, F.A.S.N.,F.A.H.A. Professor of Medicine. Director, ASH Comprehensive Hypertension Center. The University of Chicago Medicine, Chicago, IL. Dr. Bakris received his medical degree from the Chicago Medical School and completed residency in Internal Medicine at the Mayo Graduate School of Medicine where he also completed a research fellowship in Physiology and Biophysics. He then completed fellowships in Nephrology and Clinical Pharmacology at the University of Chicago. From 1988 to 1991, he served as Director of Renal Research at the Ochsner Clinic and on the faculty in the Departments of Medicine and Physiology Tulane University School of Medicine. He later was Professor and Vice Chairman of Preventive Medicine and Director of the Rush University Hypertension Center in Chicago from 1993 until 2006. Currently, he is a Professor of Medicine and Director of the ASH Comprehensive Hypertension Center in the Department of Medicine at the University of Chicago Medicine. Dr. Bakris has published over 600 articles and book chapters in the areas of diabetic kidney disease, hypertension and progression of nephropathy. He is the Editor or Co-Editor of 14 books, in the areas of Kidney Disease Progression and Diabetes and three on Kidney Function and Heart Failure. These include The Kidney and Hypertension, Hypertension: a Clinician’s Guide to Diagnosis and Treatment, Hypertension: Principles and Practice, Handbook of Hypertension, The Kidney in Cardiovascular Disease, Therapeutic Strategies in Hypertension, Chronic Kidney Disease (CKD) and Hypertension Essentials, Managing Diabetic Nephropathy in the Hypertensive Patient and others. Additionally, he is the Associate Editor of the International Textbook of Cardiology and Current Diagnosis &amp; Treatment in Nephrology. He also served as an expert-member on the Cardio-renal Advisory Board of the FDA (1993-2003) and is currently a special consultant to the FDA. He was a co-principal investigator on the NIH Clinical Research training grant for clinical research (K30) (1999-2004). He chaired the first National Kidney Foundation Consensus report on blood pressure and impact on kidney disease progression (2000). He has served on many national guideline committees including: the Joint National Committee Writing Groups VI &amp; 7 writing committees (1997, 2003), the JNC 7 executive committee (2003), the American Diabetes Association Clinical Practice Guideline Committee (2002-2004), the National Kidney Foundation (K-DOQI) Blood Pressure Guideline committee (2002-2004) and (K-DOQI) Diabetes Guideline committee (2003-2005). Dr. Bakris is also the past-President of the American College of Clinical Pharmacology (2000- 2002) and the American Society of Hypertension (ASH) (2010-2012). He is the current Editor of Am J Nephrology, the Hypertension, Section Editor of Up-to-Date and an Assoc. Ed of Diabetes Care and Nephrology, Dialysis &amp; Transplant. He serves on more than 20 different editorial boards including Kidney International, Hypertension, J Hypertension, J American Soc. Hypertension and J Clin Hypertens. 
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