Kidney Health Initiative (KHI)

KHI Current Project

Understanding and Overcoming the Challenges to Involving Patients with Kidney Disease in Cardiovascular Trials

Comment Today on Workshop Scope of Work

The KHI project workgroup, "Understanding and Overcoming the Challenges to Involving Patients with Kidney Disease in Cardiovascular Trials" is seeking your feedback to gather information from various stakeholders during a workshop that is being convened in September. We are asking that you review the proposed scope of work for this workshop and provide comments. The scope of work can be found here.

Once you have reviewed this document, please provide your feedback by following the link here. This open comment period will close on Friday, August 31. If you have any questions about this workshop, the project, or KHI in general, please contact

Patient Care Issue:

Kidney disease is highly prevalent (30% to 60%) among patients with cardiovascular disease and is a risk factor for worse cardiovascular outcomes.1,2 Thus, the management of cardiovascular disease in patients with kidney disease is a common and important clinical problem.

The evidence base to guide optimal treatment recommendations is limited. The quantity and quality of randomized trials within the field of nephrology is low, and extrapolation of trial results conducted in the general population to patients with kidney disease may or may not be appropriate.2,3 About a decade ago, two systematic reviews observed that 56% to 80% of randomized controlled trials of cardiovascular interventions excluded patients with kidney disease, and a strong recommendation was issued at that time for their greater inclusion in cardiovascular trials.1,2 In order to work towards this goal, it is necessary to understand the barriers to their inclusion using a multi-disciplinary approach with input from a variety of stakeholders.

KHI Solution:

This project has the following two objectives:

  1. Understand the barriers to inclusion of patients with kidney disease into cardiovascular trials, with a particular emphasis on those with advanced chronic kidney disease (stage 4) and end-stage renal disease
  2. Identify strategies for enhancing inclusion of patients with kidney disease into cardiovascular trials

In order to achieve these goals, drawing from the diverse membership of the Kidney Health Initiative, a workgroup of key stakeholders will be assembled: academic investigators (i.e., nephrologists and cardiologists who have conducted cardiovascular trials), academic and contract research organizations, industry, FDA, and patients with kidney disease.

The deliverable from this project will be a white paper detailing the barriers to including patients with kidney disease in cardiovascular trials and potential strategies to overcome them. It is anticipated that the workgroup meetings, data collection and analysis, and writing of the white paper will be completed within a 12-month timeframe. This project would represent a unique opportunity for a diversity of stakeholders to work together towards improving the evidence base for the management of cardiovascular disease among patients with kidney disease and could stimulate the development of areas for future research (e.g., clarification of standards for the enrollment of patients with kidney disease into trials, survey of willingness to participate in trials for patients with kidney disease).


On September 6-7, 2018 the KHI workgroup will host a workshop to discuss conducting cardiovascular clinical trials with people living with advanced stages of kidney diseases. Attendees of the workshop will assess and identify strategies and solutions in four areas:

  • Clinical trial endpoints and design
  • Financial and feasibility challenges
  • Patient engagement
  • Multi-specialty clinical trial communities

These four areas were identified from the results of the Patient and Care Partner Survey and Trial Sponsors and Other Stakeholders Survey, that were distributed last year. The workshop will convene a diverse group of stakeholders, including industry representatives, clinicians, researchers, regulators and people living with cardiovascular and kidney diseases. Following the workshop, KHI staff will develop a meeting summary that reflects the main points of discussion and recommended solutions to the barriers outlined above. To learn more, please contact Meaghan Allain, KHI Project Associate at .


Workshop and Publication.


Charles Herzog, MD, FACC, FAHA
University of Minnesota

Julie Ishida, MD, MAS
University of California

Workgroup Members:

Cynthia Chauhan
Wichita, KS

Barbara Gillespie, MD, MMS, FASN
Covance Inc.

Ken Gruchalla, MD
Health Canada

Vlado Perkovic, PhD, MBBS
The George Institute

Alain Romero, PharmD, PhD

Patrick Rossignol, MD, PhD
University of Lorraine

Kimberly Smith, MD
Food and Drug Administration

Aliza Thompson, MD
Food and Drug Administration

David Wheeler, MD
University College London

KHI Board of Directors Liaison:

Katherine R. Tuttle, MD, FASN
Providence Health Care

KHI Staff Liaison:

Meaghan Allain
KHI Project Associate

Selected References:
  1. Coca SG, Krumholz HM, Garg AX, Parikh CR. Underrepresentation of renal disease in randomized controlled trials of cardiovascular disease. JAMA. 2006;296(11):1377-1384.
  2. Charytan D, Kuntz RE. The exclusion of patients with chronic kidney disease from clinical trials in coronary artery disease. Kidney Int. 2006;70(11):2021-2030.
  3. Strippoli GF, Craig JC, Schena FP. The number, quality, and coverage of randomized controlled trials in nephrology. J Am Soc Nephrol. 2004;15(2):411-419.
Conflict of Interest

To view KHI's Conflict of Interest and Disclosure Policy please click here.