<?xml version="1.0" encoding="UTF-8"?><lom xmlns="http://ltsc.ieee.org/xsd/LOM" xmlns:lomfr="http://www.lom-fr.fr/xsd/LOMFR" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://ltsc.ieee.org/xsd/LOM http://www.lom-fr.fr/xsd/lomfrv1.0/std/lomfr.xsd">
<general>
<identifier>
<catalog>Canal-U_Ocms</catalog>
<entry>10887</entry>
</identifier>
<title><string language="fre"><![CDATA[Cardiovascular Clinical Trialists (CVCT) Forum – Interpretation and approvability issues.]]></string></title>
<language>ENG</language>
<description>
<string language="fre"><![CDATA[Title : Cardiovascular Clinical Trialists (CVCT) Forum – Interpretation and approvability issues.
Industry viewpoint: Paul AUDHYA, Reata, USA
Regulatory viewpoint: Pieter DE GRAEF, EMEA, NED
Abstract : 
L’auteur n’a pas transmis de conflit d’intérêt concernant les données diffusées dans cette vidéo ou publiées dans la référence citée.
Conférence enregistrée : 9th Global Cardiovascular Clinical Trialists Forum • Paris 2012 
Cardiovascular prevention in chronic kidney disease. New therapeutic options and future opportunities
- Cardiovascular events are 10 to 20 fold higher in CKD patients. Heart failure is the main cardiovascular complication that occurs in renal patients. Nearly all CV prevention and heart failure trials excluded patients with moderate to severe CKD. Therefore, the general approach and recommendations for CV prevention in the general population may not be equally effective and completely safe in renal patients.
- Renal failure is associated with increased vascular inflammation and oxidative stress linked to development of cardiovascular disease. Nrf-2 (NF-E2-related factor 2) is a regulator of anti-oxidant, anti-inflammatory and detoxification pathways. Intervention trials of the synthetic nrf2/nf?b modulator, bardoloxone methyl, in patients with advanced kidney disease associated with type 2 diabetes, demonstrated improvement of renal function (BEAM trial), suggesting that such agents may have therapeutic benefit in chronic renal failure.
- The ongoing BEACON trial assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease and cardiovascular deaths in patients with Stage 4 CKD and type 2 diabetes.
- More specifically in chronic hemodialysis patients, results from the very few clinical trials undertaken thus far, including trials on lipid reduction, normalization of hematocrit, and increased dialysis dosage, have been unsuccessful.
- New CV prevention opportunities are being investigated in specific trials in CKD and hemodialysis patients.
The aim of this workshop is to discuss innovative designs and execution plans of CV prevention trials in CKD as well as the interpretation and implementation of the results of such trials and the approvability - regitrsbaility of potentially new CV prevention in CKD indications.
Chairpersons: David GOLDSMITH, London, GBR - Luis RUILOPE, Madrid, ESP
Réalisation, production : Canal U/3S et CERIMES
Keyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, Baro-stimulation]]></string></description>
<keyword><string language="fre"><![CDATA[Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, Baro-stimulation]]></string></keyword>
<lomfr:documentType>
<lomfr:source>LOMFRv1.0</lomfr:source>
<lomfr:value>image en mouvement</lomfr:value>
</lomfr:documentType>
</general><lifeCycle>
<contribute>
<role>
<source>LOMv1.0</source>
<value>author</value>
</role>
<entity><![CDATA[BEGIN:VCARD
VERSION:3.0
CLASS:PUBLIC
REV:2021-07-06 15:37:15
FN:Pieter DE GRAEF
N:DE GRAEF;Pieter;;;
URL;TYPE=work:https://www.canal-u.tv/auteurs/de_graef_pieter
ROLE:author
NOTE:DE GRAEF Pieter, EMEA, NED&lt;br&gt;He was born in 1950 and finished medical training at the University of Groningen in 1975. Following a training in internal medicine at the department op Internal Medicine of the UMCG he was registered as an internist in January 1983. Subsequently, he became a clinical advisor for the MEB, maintaining a position as associate professor at the depts. of Internal Medicine and Pharmacology/Clinical Pharmacology. In 1989 he finished his thesis (PhD), In 1994 he was co-registered as a clinical pharmacologist. In 1996 he became professor in pharmacotherapeutics, responsible for implementing rational pharmacotherapy. In 2003 he was elected as “teacher of the year”. He maintained a part-time position as senior clinical adviser of the MEB as head of the regulatory cardiovascular subdivision. In 2007 he became member of the CHMP and in 2012 of the Dutch MEB. He has fulfilled a number of positions at various organisations, among which the cardiovascular subgroup WP of the EMA (since 1999 member, since 2011 chairman), the hospital Medical Ethics Committee, the hospital Pharmacotherapy Committee, and the Board of the Dutch Society Clinical Pharmacology &amp; Biopharmaceutics (chairman 1996-2000). He (co-)authored more than 100 publications in peerreviewed journals. He was involved in writing a number of regulatory cardiovascular guidelines, including those on antihypertensive, lipid-lowering and anti-arrhythmic agents. 
TZ:+0200
END:VCARD
]]></entity>
<date><dateTime>2012-12-01</dateTime></date>
</contribute>
</lifeCycle>
<metaMetadata>
<metadataSchema>LOMv1.0</metadataSchema>
<metadataSchema>LOMFRv1.0</metadataSchema>
</metaMetadata>
<technical>
<format>video/mp4</format>
<location><![CDATA[https://www.canal-u.tv/video/canal_u_medecine/cardiovascular_clinical_trialists_cvct_forum_interpretation_and_approvability_issues.10887]]></location>
<location><![CDATA[https://streaming-canal-u.fmsh.fr/vod/media/canalu/videos/cutms/cardiovascular.clinical.trialists.cvct.forum.a.interpretation.and.approvability.issues._10887/1.28.cvct2012_degraef_sd.mp4]]></location>
<location><![CDATA[https://streaming-canal-u.fmsh.fr/vod/media/canalu/videos/cutms/cardiovascular.clinical.trialists.cvct.forum.a.interpretation.and.approvability.issues._10887/1.28.cvct2012_degraef_bd.mp4]]></location>
<size>72352816</size>
<duration><duration>PT0H14M11S</duration></duration>
</technical>
<educational>
<learningResourceType>
<source>LOMv1.0</source>
<value>lecture</value>
</learningResourceType>
<context>
<source>LOMv1.0</source>
<value>higher education</value>
</context>
<context>
<source>LOMv1.0</source>
<value>formation continue</value>
</context>
</educational>
<rights>
<cost>
<source>LOMv1.0</source>
<value>no</value>
</cost>
<copyrightAndOtherRestrictions>
<source>LOMv1.0</source>
<value>no</value>
</copyrightAndOtherRestrictions>
<description>
<string language="fre"><![CDATA[Droits réservés à l'éditeur et aux auteurs. 
]]></string>
</description>
</rights>
<relation>
<kind>
<source>LOMv1.0</source>
<value>ispartof</value>
</kind>
<resource>
<identifier>
<catalog>URI</catalog>
<entry>https://www.canal-u.tv/producteurs/canal_u_medecine/cardiologie/colloque_et_evenement/cvct</entry>
</identifier>
<description>
<string language="fre"><![CDATA[CVCT 9th Global Cardiovascular Clinical Trialists Forum • Paris 2012]]></string>
</description>
</resource>
</relation>
<classification>
<purpose>
<source>LOMv1.0</source>
<value>discipline</value>
</purpose>
<taxonPath>
<source>
<string language="fre"><![CDATA[Universités Numériques Thématiques 2009 http://www.universites-numeriques.fr]]></string>
</source>
<taxon>
<id/>
<entry>
<string language="fre"/>
</entry>
</taxon>
</taxonPath>
</classification>
<classification>
<purpose>
<source>LOMv1.0</source>
<value>discipline</value>
</purpose>
<taxonPath>
<source>
<string language="fre">CDD 22e éd.</string>
<string language="eng">DDC 22nd ed.</string>
</source>
<taxon>
<id>610</id>
<entry>
<string language="fre"><![CDATA[Sciences médicales. Médecine]]></string>
</entry>
</taxon>
</taxonPath>
</classification> </lom>