Health-relatedness and Long-term Objectives: Atherosclerotic renal artery stenosis is a common problem for which there is no clear consensus on diagnosis or therapy. There likely exists a progression wherein renal ischemia leads to neuroendocdne activation, hypertension, and renal insufficiency potentially resulting in acceleration of therosclerosis, further renal dysfunction, myocardial infarction, stroke and death. The current proposal tests whether revascularization of a stenotic renal artery plus optimum medical therapy is associated with improved clinical outcomes when compared with optimum medical therapy alone.
Specific Aims, Design and Methods: Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) is a randomized clinical trial that will contrast the effect of optimum medical therapy alone to stenting with optimum medical therapy, on a composite cardiovascular and renal endpoint: cardiovascular or renal death, myocardial infarction, hospitalization for congestive heart failure, stroke, doubling of serum creatinine level, and need for renal replacement therapy. This endpoint will be adjudicated by a clinical events committee masked to treatment assignment. The secondary endpoints 1) evaluate the mechanisms linked to clinical events;2) describe differential effectiveness in critical end-organs;3) determine the value of stenting from the patient and the health policy perspectives, measured as quality of life and cost effectiveness;and 4) evaluate for clinically relevant differences in treatment effectiveness within the primary endpoint. The primary entry criteria are an atherosclerotic renal stenosis >60% with a 20 mmHg systolic pressure gradient and systolic hypertension >155 mmHg on 2 or more anti-hypertensive medications. A slight predominance of women is expected, and high priority will be placed on minority recruitment. Approximately 2200 patients will undergo a baseline evaluation with randomization occurring in 1080. The study has 90% power to detect a 28% reduction in primary endpoint hazard rate. This R01 from the Clinical Coordinating Center describes the main study hypotheses and overall trial conduct.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL071556-07
Application #
8335418
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Reid, Diane M
Project Start
2004-04-01
Project End
2014-03-31
Budget Start
2012-06-01
Budget End
2013-03-31
Support Year
7
Fiscal Year
2012
Total Cost
$1,592,393
Indirect Cost
$401,449
Name
University of Toledo
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
807418939
City
Toledo
State
OH
Country
United States
Zip Code
43614
Tuttle, Katherine R; Dworkin, Lance D; Henrich, William et al. (2016) Effects of Stenting for Atherosclerotic Renal Artery Stenosis on eGFR and Predictors of Clinical Events in the CORAL Trial. Clin J Am Soc Nephrol 11:1180-8
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Argyropoulos, Christos; Rondon-Berrios, Helbert; Raj, Dominic S et al. (2016) Hypertonicity: Pathophysiologic Concept and Experimental Studies. Cureus 8:e596
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Murphy, Timothy P; Cooper, Christopher J; Pencina, Karol M et al. (2016) Relationship of Albuminuria and Renal Artery Stent Outcomes: Results From the CORAL Randomized Clinical Trial (Cardiovascular Outcomes With Renal Artery Lesions). Hypertension 68:1145-1152
Shaver, Adam; Nichols, Alexandra; Thompson, Ellen et al. (2016) Role of Serum Biomarkers in Early Detection of Diabetic Cardiomyopathy in the West Virginian Population. Int J Med Sci 13:161-8
de Boer, Ian H; Afkarian, Maryam; Tuttle, Katherine R (2016) The Surging Tide of Diabetes: Implications for Nephrology. Am J Kidney Dis 67:364-6
Yan, Yanling; Shapiro, Joseph I (2016) The physiological and clinical importance of sodium potassium ATPase in cardiovascular diseases. Curr Opin Pharmacol 27:43-9

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