Hypertension Clinical Trial
To examine the epidemiology of renal disease and its relationship to cardiovascular disease.
BACKGROUND:
Mild-to-moderate chronic renal insufficiency (CRI) has been reaching epidemic proportions in
the United States. Studies relating mild-to-moderate chronic renal insufficiency and
cardiovascular risk were limited and inconsistent. Although much had been learned about the
natural history and adverse outcomes associated with end-stage renal disease (ESRD), there
was little specific information regarding risk factors for the development or progression of
renal disease.
The study was initiated in response to a Request for Applications entitled "NHLBI Innovative
Research Grant Program" released in July, 2001. The purpose of the initiative was to support
new approaches to heart, lung, and blood diseases and sleep disorders that used existing
data sets or existing biological specimen collections whether obtained through National
Heart, Lung, and Blood Institute support or not.
DESIGN NARRATIVE:
The population-based study used data on an ethnically diverse large cohort of male and
female health plan enrollees with extended follow-up. The study evaluated: a) whether
baseline and decline in renal function over time were independent predictors of coronary
heart disease (CHD), stroke, heart failure and peripheral vascular disease; b) effect
modifiers of these relationships,including baseline hypertension and diabetes status. The
study determined whether baseline and increase over time in blood pressure level (as well as
prevalent and incident hypertension) were predictive of the subsequent risk of ESRD after
adjusting for diabetes and for baseline serum creatinine, proteinuria and hematuria. The
study also examined other potential predictors of ESRD including demographic factors
(race/ethnicity, level of education) total cholesterol level, family history of renal
disease, body mass index, sagittal abdominal diameter, cigarette (as well as cigar and pipe)
smoking, coffee intake, alcohol consumption, family history of renal disease and
self-reported occupational exposures. The study used existing longitudinal data resources at
the Northern California Kaiser Permanente Division of Research and available patient-level
cross-linkage with the US Renal Data System end-stage renal disease registry to obtain
comprehensive renal and cardiovascular outcomes.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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