Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints.
Identifieur interne : 001045 ( Main/Exploration ); précédent : 001044; suivant : 001046Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints.
Auteurs : Patrick Rossignol [France] ; Rajiv Agarwal [États-Unis] ; Bernard Canaud [France] ; Alan Charney [États-Unis] ; Gilles Chatellier [France] ; Jonathan C. Craig [Australie] ; William C. Cushman [États-Unis] ; Ronald T. Gansevoort [Pays-Bas] ; Bengt Fellström [France] ; Dahlia Garza [États-Unis] ; Nicolas Guzman [États-Unis] ; Frank A. Holtkamp [Pays-Bas] ; Gerard M. London [France] ; Ziad A. Massy [France] ; Alexandre Mebazaa [France] ; Peter G M. Mol [Pays-Bas] ; Marc A. Pfeffer [États-Unis] ; Yves Rosenberg [États-Unis] ; Luis M. Ruilope [Espagne] ; Jonathan Seltzer [États-Unis] ; Amil M. Shah [États-Unis] ; Salim Shah [États-Unis] ; Bhupinder Singh [États-Unis] ; Bergur V. Stefánsson [Suède] ; Norman Stockbridge [États-Unis] ; Wendy Gattis Stough [États-Unis] ; Kristian Thygesen [Danemark] ; Michael Walsh [Canada] ; Christoph Wanner [Allemagne] ; David G. Warnock [États-Unis] ; Christopher S. Wilcox [États-Unis] ; Janet Wittes [États-Unis] ; Bertram Pitt [États-Unis] ; Aliza Thompson [États-Unis] ; Faiez Zannad [France]Source :
- European heart journal [ 1522-9645 ] ; 2017.
Abstract
Although cardiovascular disease is a major health burden for patients with chronic kidney disease, most cardiovascular outcome trials have excluded patients with advanced chronic kidney disease. Moreover, the major cardiovascular outcome trials that have been conducted in patients with end-stage renal disease have not demonstrated a treatment benefit. Thus, clinicians have limited evidence to guide the management of cardiovascular disease in patients with chronic kidney disease, particularly those on dialysis. Several factors contribute to both the paucity of trials and the apparent lack of observed treatment effect in completed studies. Challenges associated with conducting trials in this population include patient heterogeneity, complexity of renal pathophysiology and its interaction with cardiovascular disease, and competing risks for death. The Investigator Network Initiative Cardiovascular and Renal Clinical Trialists (INI-CRCT), an international organization of academic cardiovascular and renal clinical trialists, held a meeting of regulators and experts in nephrology, cardiology, and clinical trial methodology. The group identified several research priorities, summarized in this paper, that should be pursued to advance the field towards achieving improved cardiovascular outcomes for these patients. Cardiovascular and renal clinical trialists must partner to address the uncertainties in the field through collaborative research and design clinical trials that reflect the specific needs of the chronic and end-stage kidney disease populations, with the shared goal of generating robust evidence to guide the management of cardiovascular disease in patients with kidney disease.
DOI: 10.1093/eurheartj/ehx209
PubMed: 28431138
Affiliations:
- Allemagne, Australie, Canada, Danemark, Espagne, France, Pays-Bas, Suède, États-Unis
- Alabama, Bavière, Californie, Caroline du Nord, Communauté de Madrid, District de Basse-Franconie, District de Columbia, Grand Est, Groningue (province), Indiana, Lorraine (région), Maryland, Massachusetts, Michigan, New Jersey, Nouvelle-Galles du Sud, Pennsylvanie, Tennessee, Utrecht (province), Virginie, Île-de-France
- Groningue, Madrid, Nancy, Paris, Sydney, Utrecht, Wurtzbourg
- Université de Sydney
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Wilcox</name><affiliation wicri:level="2"><nlm:affiliation>Hypertension, Kidney and Vascular Research Center and Division of Nephrology and Hypertension, Department of Medicine, Georgetown University, Washington, DC, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Hypertension, Kidney and Vascular Research Center and Division of Nephrology and Hypertension, Department of Medicine, Georgetown University, Washington, DC</wicri:regionArea><placeName><region type="state">District de Columbia</region></placeName></affiliation></author><author><name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name><affiliation wicri:level="1"><nlm:affiliation>Statistics Collaborative, Inc., Washington, District of Columbia, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Statistics Collaborative, Inc., Washington, District of Columbia</wicri:regionArea><wicri:noRegion>District of Columbia</wicri:noRegion></affiliation></author><author><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name><affiliation wicri:level="2"><nlm:affiliation>University of Michigan School of Medicine, Ann Arbor, MI, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Michigan School of Medicine, Ann Arbor, MI</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Thompson, Aliza" sort="Thompson, Aliza" uniqKey="Thompson A" first="Aliza" last="Thompson">Aliza Thompson</name><affiliation wicri:level="2"><nlm:affiliation>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name><affiliation wicri:level="3"><nlm:affiliation>Inserm, Centre d'Investigations Cliniques- 1433, and Inserm U1116; CHRU Nancy; Université de Lorraine; Association Lorraine pour le Traitement de l'Insuffisance Rénale, Institut lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 rue du Morvan, 54500, Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Inserm, Centre d'Investigations Cliniques- 1433, and Inserm U1116; CHRU Nancy; Université de Lorraine; Association Lorraine pour le Traitement de l'Insuffisance Rénale, Institut lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 rue du Morvan, 54500, Nancy</wicri:regionArea><placeName><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28431138</idno><idno type="pmid">28431138</idno><idno type="doi">10.1093/eurheartj/ehx209</idno><idno type="wicri:Area/PubMed/Corpus">000E32</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000E32</idno><idno type="wicri:Area/PubMed/Curation">000E29</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000E29</idno><idno type="wicri:Area/PubMed/Checkpoint">000E29</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000E29</idno><idno type="wicri:Area/Ncbi/Merge">004674</idno><idno type="wicri:Area/Ncbi/Curation">004674</idno><idno type="wicri:Area/Ncbi/Checkpoint">004674</idno><idno type="wicri:Area/Main/Merge">001040</idno><idno type="wicri:Area/Main/Curation">001045</idno><idno type="wicri:Area/Main/Exploration">001045</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints.</title><author><name sortKey="Rossignol, Patrick" sort="Rossignol, Patrick" uniqKey="Rossignol P" first="Patrick" last="Rossignol">Patrick Rossignol</name><affiliation wicri:level="3"><nlm:affiliation>Inserm, Centre d'Investigations Cliniques- 1433, and Inserm U1116; CHRU Nancy; Université de Lorraine; Association Lorraine pour le Traitement de l'Insuffisance Rénale, Institut lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 rue du Morvan, 54500, Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Inserm, Centre d'Investigations Cliniques- 1433, and Inserm U1116; CHRU Nancy; Université de Lorraine; Association Lorraine pour le Traitement de l'Insuffisance Rénale, Institut lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 rue du Morvan, 54500, Nancy</wicri:regionArea><placeName><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName></affiliation></author><author><name sortKey="Agarwal, Rajiv" sort="Agarwal, Rajiv" uniqKey="Agarwal R" first="Rajiv" last="Agarwal">Rajiv Agarwal</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, Indiana University School of Medicine, Indianapolis, IN</wicri:regionArea><placeName><region type="state">Indiana</region></placeName></affiliation></author><author><name sortKey="Canaud, Bernard" sort="Canaud, Bernard" uniqKey="Canaud B" first="Bernard" last="Canaud">Bernard Canaud</name><affiliation wicri:level="1"><nlm:affiliation>Fresenius Medical Care Deutschland and University of Montpellier, UFR Medicine, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Fresenius Medical Care Deutschland and University of Montpellier, UFR Medicine</wicri:regionArea><wicri:noRegion>UFR Medicine</wicri:noRegion><wicri:noRegion>UFR Medicine</wicri:noRegion></affiliation></author><author><name sortKey="Charney, Alan" sort="Charney, Alan" uniqKey="Charney A" first="Alan" last="Charney">Alan Charney</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Chatellier, Gilles" sort="Chatellier, Gilles" uniqKey="Chatellier G" first="Gilles" last="Chatellier">Gilles Chatellier</name><affiliation wicri:level="3"><nlm:affiliation>AP-HP, Hôpital Européen Georges Pompidou, Unité de Recherche Clinique and INSERM CIC 1418, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>AP-HP, Hôpital Européen Georges Pompidou, Unité de Recherche Clinique and INSERM CIC 1418, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Craig, Jonathan C" sort="Craig, Jonathan C" uniqKey="Craig J" first="Jonathan C" last="Craig">Jonathan C. Craig</name><affiliation wicri:level="4"><nlm:affiliation>School of Public Health, The University of Sydney, New South Wales, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>School of Public Health, The University of Sydney, New South Wales</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Cushman, William C" sort="Cushman, William C" uniqKey="Cushman W" first="William C" last="Cushman">William C. Cushman</name><affiliation wicri:level="2"><nlm:affiliation>Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, Tennessee, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, Tennessee</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Gansevoort, Ronald T" sort="Gansevoort, Ronald T" uniqKey="Gansevoort R" first="Ronald T" last="Gansevoort">Ronald T. Gansevoort</name><affiliation wicri:level="3"><nlm:affiliation>Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Fellstrom, Bengt" sort="Fellstrom, Bengt" uniqKey="Fellstrom B" first="Bengt" last="Fellström">Bengt Fellström</name><affiliation wicri:level="1"><nlm:affiliation>Inserm U1018, Université Paris-Saclay, UVSQ, Université. Paris-Sud, Villejuif, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Inserm U1018, Université Paris-Saclay, UVSQ, Université. Paris-Sud, Villejuif</wicri:regionArea><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author><author><name sortKey="Garza, Dahlia" sort="Garza, Dahlia" uniqKey="Garza D" first="Dahlia" last="Garza">Dahlia Garza</name><affiliation wicri:level="2"><nlm:affiliation>Relypsa, Inc., Redwood City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Relypsa, Inc., Redwood City, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Guzman, Nicolas" sort="Guzman, Nicolas" uniqKey="Guzman N" first="Nicolas" last="Guzman">Nicolas Guzman</name><affiliation wicri:level="2"><nlm:affiliation>AstraZeneca, Gaithersburg, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AstraZeneca, Gaithersburg, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Holtkamp, Frank A" sort="Holtkamp, Frank A" uniqKey="Holtkamp F" first="Frank A" last="Holtkamp">Frank A. Holtkamp</name><affiliation wicri:level="3"><nlm:affiliation>Dutch Medicines Evaluation Board, Utrecht, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Dutch Medicines Evaluation Board, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="London, Gerard M" sort="London, Gerard M" uniqKey="London G" first="Gerard M" last="London">Gerard M. London</name><affiliation wicri:level="3"><nlm:affiliation>F-CRIN INI-CRCT, Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>F-CRIN INI-CRCT, Nancy</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName></affiliation></author><author><name sortKey="Massy, Ziad A" sort="Massy, Ziad A" uniqKey="Massy Z" first="Ziad A" last="Massy">Ziad A. Massy</name><affiliation wicri:level="3"><nlm:affiliation>F-CRIN INI-CRCT, Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>F-CRIN INI-CRCT, Nancy</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName></affiliation></author><author><name sortKey="Mebazaa, Alexandre" sort="Mebazaa, Alexandre" uniqKey="Mebazaa A" first="Alexandre" last="Mebazaa">Alexandre Mebazaa</name><affiliation wicri:level="3"><nlm:affiliation>F-CRIN INI-CRCT, Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>F-CRIN INI-CRCT, Nancy</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName></affiliation></author><author><name sortKey="Mol, Peter G M" sort="Mol, Peter G M" uniqKey="Mol P" first="Peter G M" last="Mol">Peter G M. Mol</name><affiliation wicri:level="3"><nlm:affiliation>Dutch Medicines Evaluation Board, Utrecht, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Dutch Medicines Evaluation Board, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Pfeffer, Marc A" sort="Pfeffer, Marc A" uniqKey="Pfeffer M" first="Marc A" last="Pfeffer">Marc A. Pfeffer</name><affiliation wicri:level="2"><nlm:affiliation>Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Rosenberg, Yves" sort="Rosenberg, Yves" uniqKey="Rosenberg Y" first="Yves" last="Rosenberg">Yves Rosenberg</name><affiliation wicri:level="2"><nlm:affiliation>National Heart, Lung, and Blood Institute, Bethesda, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>National Heart, Lung, and Blood Institute, Bethesda, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Ruilope, Luis M" sort="Ruilope, Luis M" uniqKey="Ruilope L" first="Luis M" last="Ruilope">Luis M. Ruilope</name><affiliation wicri:level="3"><nlm:affiliation>Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Department of Preventive Medicine and Public Health, Universidad Autonoma and School of Doctoral Studies and Research, Universidad Europea de Madrid, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Department of Preventive Medicine and Public Health, Universidad Autonoma and School of Doctoral Studies and Research, Universidad Europea de Madrid, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Seltzer, Jonathan" sort="Seltzer, Jonathan" uniqKey="Seltzer J" first="Jonathan" last="Seltzer">Jonathan Seltzer</name><affiliation wicri:level="2"><nlm:affiliation>ACI Clinical, Bala Cynwyd, PA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>ACI Clinical, Bala Cynwyd, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Shah, Amil M" sort="Shah, Amil M" uniqKey="Shah A" first="Amil M" last="Shah">Amil M. Shah</name><affiliation wicri:level="2"><nlm:affiliation>Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Shah, Salim" sort="Shah, Salim" uniqKey="Shah S" first="Salim" last="Shah">Salim Shah</name><affiliation wicri:level="2"><nlm:affiliation>Sarfez Pharmaceuticals, Inc., McLean, VA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Sarfez Pharmaceuticals, Inc., McLean, VA</wicri:regionArea><placeName><region type="state">Virginie</region></placeName></affiliation></author><author><name sortKey="Singh, Bhupinder" sort="Singh, Bhupinder" uniqKey="Singh B" first="Bhupinder" last="Singh">Bhupinder Singh</name><affiliation wicri:level="2"><nlm:affiliation>ZS Pharma, San Mateo, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>ZS Pharma, San Mateo, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Stefansson, Bergur V" sort="Stefansson, Bergur V" uniqKey="Stefansson B" first="Bergur V" last="Stefánsson">Bergur V. Stefánsson</name><affiliation wicri:level="1"><nlm:affiliation>AstraZeneca, Gothenburg, Sweden.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>AstraZeneca, Gothenburg</wicri:regionArea><wicri:noRegion>Gothenburg</wicri:noRegion></affiliation></author><author><name sortKey="Stockbridge, Norman" sort="Stockbridge, Norman" uniqKey="Stockbridge N" first="Norman" last="Stockbridge">Norman Stockbridge</name><affiliation wicri:level="2"><nlm:affiliation>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Stough, Wendy Gattis" sort="Stough, Wendy Gattis" uniqKey="Stough W" first="Wendy Gattis" last="Stough">Wendy Gattis Stough</name><affiliation wicri:level="2"><nlm:affiliation>Campbell University College of Pharmacy and Health Sciences, NC, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Campbell University College of Pharmacy and Health Sciences, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Thygesen, Kristian" sort="Thygesen, Kristian" uniqKey="Thygesen K" first="Kristian" last="Thygesen">Kristian Thygesen</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Cardiology, Aarhus University Hospital, Aarhus</wicri:regionArea><wicri:noRegion>Aarhus</wicri:noRegion></affiliation></author><author><name sortKey="Walsh, Michael" sort="Walsh, Michael" uniqKey="Walsh M" first="Michael" last="Walsh">Michael Walsh</name><affiliation wicri:level="1"><nlm:affiliation>McMaster University and Population Health Research Institute, Hamilton, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>McMaster University and Population Health Research Institute, Hamilton</wicri:regionArea><wicri:noRegion>Hamilton</wicri:noRegion></affiliation></author><author><name sortKey="Wanner, Christoph" sort="Wanner, Christoph" uniqKey="Wanner C" first="Christoph" last="Wanner">Christoph Wanner</name><affiliation wicri:level="3"><nlm:affiliation>Division of Nephrology, Department of Internal Medicine 1, University Hospital Würzburg and Comprehensive Heart Failure Center, Würzburg, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Division of Nephrology, Department of Internal Medicine 1, University Hospital Würzburg and Comprehensive Heart Failure Center, Würzburg</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Basse-Franconie</region><settlement type="city">Wurtzbourg</settlement></placeName></affiliation></author><author><name sortKey="Warnock, David G" sort="Warnock, David G" uniqKey="Warnock D" first="David G" last="Warnock">David G. Warnock</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of Alabama at Birmingham, Birmingham, AL</wicri:regionArea><placeName><region type="state">Alabama</region></placeName></affiliation></author><author><name sortKey="Wilcox, Christopher S" sort="Wilcox, Christopher S" uniqKey="Wilcox C" first="Christopher S" last="Wilcox">Christopher S. Wilcox</name><affiliation wicri:level="2"><nlm:affiliation>Hypertension, Kidney and Vascular Research Center and Division of Nephrology and Hypertension, Department of Medicine, Georgetown University, Washington, DC, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Hypertension, Kidney and Vascular Research Center and Division of Nephrology and Hypertension, Department of Medicine, Georgetown University, Washington, DC</wicri:regionArea><placeName><region type="state">District de Columbia</region></placeName></affiliation></author><author><name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name><affiliation wicri:level="1"><nlm:affiliation>Statistics Collaborative, Inc., Washington, District of Columbia, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Statistics Collaborative, Inc., Washington, District of Columbia</wicri:regionArea><wicri:noRegion>District of Columbia</wicri:noRegion></affiliation></author><author><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name><affiliation wicri:level="2"><nlm:affiliation>University of Michigan School of Medicine, Ann Arbor, MI, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Michigan School of Medicine, Ann Arbor, MI</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Thompson, Aliza" sort="Thompson, Aliza" uniqKey="Thompson A" first="Aliza" last="Thompson">Aliza Thompson</name><affiliation wicri:level="2"><nlm:affiliation>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name><affiliation wicri:level="3"><nlm:affiliation>Inserm, Centre d'Investigations Cliniques- 1433, and Inserm U1116; CHRU Nancy; Université de Lorraine; Association Lorraine pour le Traitement de l'Insuffisance Rénale, Institut lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 rue du Morvan, 54500, Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Inserm, Centre d'Investigations Cliniques- 1433, and Inserm U1116; CHRU Nancy; Université de Lorraine; Association Lorraine pour le Traitement de l'Insuffisance Rénale, Institut lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 rue du Morvan, 54500, Nancy</wicri:regionArea><placeName><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName></affiliation></author></analytic><series><title level="j">European heart journal</title><idno type="eISSN">1522-9645</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Although cardiovascular disease is a major health burden for patients with chronic kidney disease, most cardiovascular outcome trials have excluded patients with advanced chronic kidney disease. Moreover, the major cardiovascular outcome trials that have been conducted in patients with end-stage renal disease have not demonstrated a treatment benefit. Thus, clinicians have limited evidence to guide the management of cardiovascular disease in patients with chronic kidney disease, particularly those on dialysis. Several factors contribute to both the paucity of trials and the apparent lack of observed treatment effect in completed studies. Challenges associated with conducting trials in this population include patient heterogeneity, complexity of renal pathophysiology and its interaction with cardiovascular disease, and competing risks for death. The Investigator Network Initiative Cardiovascular and Renal Clinical Trialists (INI-CRCT), an international organization of academic cardiovascular and renal clinical trialists, held a meeting of regulators and experts in nephrology, cardiology, and clinical trial methodology. The group identified several research priorities, summarized in this paper, that should be pursued to advance the field towards achieving improved cardiovascular outcomes for these patients. Cardiovascular and renal clinical trialists must partner to address the uncertainties in the field through collaborative research and design clinical trials that reflect the specific needs of the chronic and end-stage kidney disease populations, with the shared goal of generating robust evidence to guide the management of cardiovascular disease in patients with kidney disease.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>Danemark</li><li>Espagne</li><li>France</li><li>Pays-Bas</li><li>Suède</li><li>États-Unis</li></country><region><li>Alabama</li><li>Bavière</li><li>Californie</li><li>Caroline du Nord</li><li>Communauté de Madrid</li><li>District de Basse-Franconie</li><li>District de Columbia</li><li>Grand Est</li><li>Groningue (province)</li><li>Indiana</li><li>Lorraine (région)</li><li>Maryland</li><li>Massachusetts</li><li>Michigan</li><li>New Jersey</li><li>Nouvelle-Galles du Sud</li><li>Pennsylvanie</li><li>Tennessee</li><li>Utrecht (province)</li><li>Virginie</li><li>Île-de-France</li></region><settlement><li>Groningue</li><li>Madrid</li><li>Nancy</li><li>Paris</li><li>Sydney</li><li>Utrecht</li><li>Wurtzbourg</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="France"><region name="Grand Est"><name sortKey="Rossignol, Patrick" sort="Rossignol, Patrick" uniqKey="Rossignol P" first="Patrick" last="Rossignol">Patrick Rossignol</name></region><name sortKey="Canaud, Bernard" sort="Canaud, Bernard" uniqKey="Canaud B" first="Bernard" last="Canaud">Bernard Canaud</name><name sortKey="Chatellier, Gilles" sort="Chatellier, Gilles" uniqKey="Chatellier G" first="Gilles" last="Chatellier">Gilles Chatellier</name><name sortKey="Fellstrom, Bengt" sort="Fellstrom, Bengt" uniqKey="Fellstrom B" first="Bengt" last="Fellström">Bengt Fellström</name><name sortKey="London, Gerard M" sort="London, Gerard M" uniqKey="London G" first="Gerard M" last="London">Gerard M. 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Cushman</name><name sortKey="Garza, Dahlia" sort="Garza, Dahlia" uniqKey="Garza D" first="Dahlia" last="Garza">Dahlia Garza</name><name sortKey="Guzman, Nicolas" sort="Guzman, Nicolas" uniqKey="Guzman N" first="Nicolas" last="Guzman">Nicolas Guzman</name><name sortKey="Pfeffer, Marc A" sort="Pfeffer, Marc A" uniqKey="Pfeffer M" first="Marc A" last="Pfeffer">Marc A. Pfeffer</name><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name><name sortKey="Rosenberg, Yves" sort="Rosenberg, Yves" uniqKey="Rosenberg Y" first="Yves" last="Rosenberg">Yves Rosenberg</name><name sortKey="Seltzer, Jonathan" sort="Seltzer, Jonathan" uniqKey="Seltzer J" first="Jonathan" last="Seltzer">Jonathan Seltzer</name><name sortKey="Shah, Amil M" sort="Shah, Amil M" uniqKey="Shah A" first="Amil M" last="Shah">Amil M. Shah</name><name sortKey="Shah, Salim" sort="Shah, Salim" uniqKey="Shah S" first="Salim" last="Shah">Salim Shah</name><name sortKey="Singh, Bhupinder" sort="Singh, Bhupinder" uniqKey="Singh B" first="Bhupinder" last="Singh">Bhupinder Singh</name><name sortKey="Stockbridge, Norman" sort="Stockbridge, Norman" uniqKey="Stockbridge N" first="Norman" last="Stockbridge">Norman Stockbridge</name><name sortKey="Stough, Wendy Gattis" sort="Stough, Wendy Gattis" uniqKey="Stough W" first="Wendy Gattis" last="Stough">Wendy Gattis Stough</name><name sortKey="Thompson, Aliza" sort="Thompson, Aliza" uniqKey="Thompson A" first="Aliza" last="Thompson">Aliza Thompson</name><name sortKey="Warnock, David G" sort="Warnock, David G" uniqKey="Warnock D" first="David G" last="Warnock">David G. Warnock</name><name sortKey="Wilcox, Christopher S" sort="Wilcox, Christopher S" uniqKey="Wilcox C" first="Christopher S" last="Wilcox">Christopher S. Wilcox</name><name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Craig, Jonathan C" sort="Craig, Jonathan C" uniqKey="Craig J" first="Jonathan C" last="Craig">Jonathan C. Craig</name></region></country><country name="Pays-Bas"><region name="Groningue (province)"><name sortKey="Gansevoort, Ronald T" sort="Gansevoort, Ronald T" uniqKey="Gansevoort R" first="Ronald T" last="Gansevoort">Ronald T. Gansevoort</name></region><name sortKey="Holtkamp, Frank A" sort="Holtkamp, Frank A" uniqKey="Holtkamp F" first="Frank A" last="Holtkamp">Frank A. Holtkamp</name><name sortKey="Mol, Peter G M" sort="Mol, Peter G M" uniqKey="Mol P" first="Peter G M" last="Mol">Peter G M. Mol</name></country><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Ruilope, Luis M" sort="Ruilope, Luis M" uniqKey="Ruilope L" first="Luis M" last="Ruilope">Luis M. Ruilope</name></region></country><country name="Suède"><noRegion><name sortKey="Stefansson, Bergur V" sort="Stefansson, Bergur V" uniqKey="Stefansson B" first="Bergur V" last="Stefánsson">Bergur V. Stefánsson</name></noRegion></country><country name="Danemark"><noRegion><name sortKey="Thygesen, Kristian" sort="Thygesen, Kristian" uniqKey="Thygesen K" first="Kristian" last="Thygesen">Kristian Thygesen</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Walsh, Michael" sort="Walsh, Michael" uniqKey="Walsh M" first="Michael" last="Walsh">Michael Walsh</name></noRegion></country><country name="Allemagne"><region name="Bavière"><name sortKey="Wanner, Christoph" sort="Wanner, Christoph" uniqKey="Wanner C" first="Christoph" last="Wanner">Christoph Wanner</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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