Article open access publication

Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints.

European Heart Journal, Oxford University Press (OUP), ISSN 1522-9645

Volume 40, 11, 2017

DOI:10.1093/eurheartj/ehx209, Dimensions: pub.1084183765, PMC: PMC6657268, PMID: 28431138,



  1. (1) F-CRIN INI-CRCT, Nancy, France.
  2. (2) Centre Hospitalier Universitaire de Nancy, grid.410527.5
  3. (3) University of Lorraine, grid.29172.3f
  4. (4) Indiana University – Purdue University Indianapolis, grid.257413.6
  5. (5) Richard L. Roudebush VA Medical Center, grid.280828.8
  6. (6) Fresenius Medical Care (Germany), grid.415062.4
  7. (7) University of Montpellier, grid.121334.6
  8. (8) Novartis (United States), grid.418424.f
  9. (9) Hôpital Européen Georges-Pompidou, grid.414093.b
  10. (10) Children's Hospital at Westmead, grid.413973.b
  11. (11) University of Sydney, grid.1013.3
  12. (12) Memphis VA Medical Center, grid.413847.d
  13. (13) University of Groningen, grid.4830.f
  14. (14) University Medical Center Groningen, grid.4494.d
  15. (15) Centre for research in epidemiology and population health, grid.463845.8
  16. (16) Relypsa, Inc., Redwood City, CA, USA.
  17. (17) AstraZeneca (United States), grid.418152.b
  18. (18) Medicines Evaluation Board, grid.491235.8
  19. (19) Centre Hospitalier Frèderic-Henri Manhès, grid.418088.d
  20. (20) Hôpital Ambroise-Paré, grid.413756.2
  21. (21) Assistance Publique -Hopitaux De Paris, grid.50550.35
  22. (22) French Institute of Health and Medical Research, grid.7429.8
  23. (23) University of Paris, grid.508487.6
  24. (24) Harvard University, grid.38142.3c
  25. (25) National Heart Lung and Blood Institute, grid.279885.9
  26. (26) Hospital Universitario 12 De Octubre, grid.144756.5
  27. (27) ACI Clinical, Bala Cynwyd, PA, USA.
  28. (28) Sarfez (United States), grid.505204.6
  29. (29) ZS Pharma, San Mateo, CA, USA.
  30. (30) AstraZeneca (Sweden), grid.418151.8
  31. (31) Center for Drug Evaluation and Research, grid.483500.a
  32. (32) Campbell University, grid.253606.4
  33. (33) Aarhus University Hospital, grid.154185.c, Central Denmark Region
  34. (34) Population Health Research Institute, grid.415102.3
  35. (35) University Hospital Würzburg, grid.411760.5
  36. (36) University of Alabama at Birmingham, grid.265892.2
  37. (37) Georgetown University, grid.213910.8
  38. (38) Statistics Collaborative, grid.437929.2
  39. (39) University of Michigan, grid.214458.e


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.

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