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Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of
Patrick Rossignol1,2, Rajiv Agarwal3,4, Bernard Canaud5
1Inserm, 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, Nancy, France.
European Heart Journal
|April 22, 2017
Summary
Cardiovascular disease is a major concern for chronic kidney disease (CKD) patients, but trials exclude many. Research is needed to guide treatment for CKD patients, especially those on dialysis, to improve cardiovascular outcomes.
Area of Science:
- Nephrology and Cardiology
- Clinical Trial Methodology
Background:
- Cardiovascular disease (CVD) is a significant health burden in chronic kidney disease (CKD) patients.
- Most cardiovascular outcome trials exclude patients with advanced CKD or end-stage renal disease (ESRD).
- Limited evidence exists to guide CVD management in CKD patients, particularly those on dialysis.
Purpose of the Study:
- To identify research priorities for improving cardiovascular outcomes in patients with CKD.
- To address the paucity of clinical trials and lack of demonstrated treatment benefit in this population.
Main Methods:
- A meeting was convened by the Investigator Network Initiative Cardiovascular and Renal Clinical Trialists (INI-CRCT).
- Participants included regulators and experts in nephrology, cardiology, and clinical trial methodology.
- Research priorities were identified and summarized.
Main Results:
- Challenges in trial conduct include patient heterogeneity, complex pathophysiology, and competing risks.
- Identified research priorities aim to advance the field of cardiovascular care in CKD.
- Collaboration between cardiovascular and renal trialists is crucial.
Conclusions:
- There is a critical need for collaborative research to address uncertainties in managing CVD in CKD patients.
- Future clinical trials must be designed to meet the specific needs of CKD and ESRD populations.
- Generating robust evidence is essential for guiding effective CVD management in kidney disease patients.
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