Kidney Disease Patients at Risk, but Often Excluded from Heart Studies

Chirag Parikh, M.D. Despite a high risk for cardiovascular death, patients with chronic kidney disease (CKD) are frequently excluded from cardiovascular trials, researchers at Yale School of Medicine report in the Journal of the American Medical Association (JAMA).
Chirag Parikh, M.D.

Despite a high risk for cardiovascular death, patients with chronic kidney disease (CKD) are frequently excluded from cardiovascular trials, researchers at Yale School of Medicine report in the Journal of the American Medical Association (JAMA).

The researchers also found that published trials provide no information on renal function in participants or the effect of interventions on participants with renal disease. This results in poor information on how to treat cardiovascular disease in CKD patients.

“Inclusion and reporting of kidney disease patients in cardiovascular trials must improve,” said senior investigator Chirag Parikh, M.D., assistant professor in the Section of Nephrology at the Yale School of Medicine. “Alternatively, we need to design separate trials for cardiovascular treatment exclusively in CKD patients.”

Parikh and Steven Coca, renal fellow at Yale, reviewed 153 clinical trials for treatment of cardiovascular disease from 11 major medical and subspecialty journals published from 1985 through 2005. Patients with kidney disease were excluded from 56 percent of the trials and were also more likely to be excluded from multi-center trials. Only five percent of original articles reported the proportion of enrolled patients with renal disease and only 10 percent reported mean baseline renal function.

Cardiovascular death remains the leading cause of death in patients with CKD and over nine million people in the U.S. have CKD.

Parikh and Coca, who are also affiliated with the Clinical Epidemiology Research Center at the VA Connecticut Healthcare System, said there are many biological reasons cardiovascular disease in patients with CKD may be different from that in general population and interfere with effectiveness of existing therapies and prognosis. Patients with CKD have abnormally high levels of protein in their urine, elevated homocysteine levels, and a higher burden of hypertension, anemia and inflammatory factors.

“We strongly urge researchers to universally adopt standards for reporting of renal disease in cardiovascular studies,” said Parikh. “Funding agencies should make these studies a priority to gather information in this increasingly important subgroup of patients.”

Other authors on the study included Harlan M. Krumholz, M.D., and Amit X. Garg, M.D.

Citation: JAMA, Vol. 296, No. 11 (September 20, 2006)

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Karen N. Peart: karen.peart@yale.edu, 203-980-2222