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Rationale and design of the Eplerenone combination Versus conventional Agents to Lower blood pressure on Urinary Antialbuminuric Treatment Effect (EVALUATE) trial: a double-blinded randomized placebo-controlled trial to evaluate the antialbuminuric effects of an aldosterone blocker in hypertensive patients with albuminuria.

Author(s): Ando K, Ohtsu H, Arakawa Y, Kubota K, Yamaguchi T, Nagase M, Yamada A, Fujita T; Eplerenone combination Versus conventional Agents to Lower blood pressure on Urinary Antialbuminuric Treatment Effect Study Investigators.

Collaborators: Fujita T, Yamada A, Fujita T, Yamada A, Kimura K, Uchida S, Yamada A, Ando K, Nishikawa T, Sato A, Nagase M, Fujita T, Seki G, Tojo A, Nangaku M, Shimosawa T, Kaname S, Shibagaki Y, Suzuki H, Nakajima K, Yanagihara Y, Arakawa Y, Aoki A, Yamaguchi T, Ohtsu H, Kiuchi T, Nishiuchi H, Kubota K, Yamazaki T, Tatsunami S, Imasawa T.

Affiliation(s): Department of Nephrology and Endocrinology, Faculty of Medicine, University of Tokyo Hospital, Tokyo, Japan.

Publication date & source: 2010, Hypertens Res. , 33(6):616-21

Although inhibitors of the renin-angiotensin system are effective as first-line antihypertensive drugs in hypertensive patients with chronic kidney disease, they cannot completely prevent the progression of renal injury. Many animal studies, including our own, and a few human studies suggest that mineralocorticoid receptor blockade could inhibit the ongoing renal damage in chronic kidney disease. Thus, we designed this double-blinded, randomized, placebo-controlled trial to evaluate the antialbuminuric effect of a low dose (50 mg day(-1)) of the mineralocorticoid receptor antagonist eplerenone. The study subjects will include 340 hypertensive patients (blood pressure: 130-180/80-100 mm Hg) with albuminuria (urinary albumin/creatinine ratio: 30-600 mg g(-1) in the first morning void urine), who are treated with an inhibitor of the renin-angiotensin system. Other classes of antihypertensive drugs may be added as needed to achieve the target blood pressure (<130/80 mm Hg). The primary study end point is the change in the urinary albumin/creatinine ratio after a 1-year study period. This trial is expected to show whether a low dose of mineralocorticoid receptor antagonists can exert an antialbuminuric effect in patients with chronic kidney disease.

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