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

Hypertens Res. 2010 Jun;33(6):616-21. doi: 10.1038/hr.2010.46. Epub 2010 Apr 9.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Albuminuria / complications
  • Albuminuria / drug therapy*
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Antihypertensive Agents / therapeutic use
  • Blood Pressure / drug effects*
  • Chronic Disease
  • Creatine / blood
  • Drug Therapy, Combination
  • Eplerenone
  • Female
  • Humans
  • Hypertension / complications
  • Hypertension / drug therapy*
  • Kidney / drug effects
  • Kidney / physiopathology
  • Kidney Diseases / drug therapy
  • Male
  • Middle Aged
  • Mineralocorticoid Receptor Antagonists / therapeutic use*
  • Sodium Chloride, Dietary / adverse effects
  • Spironolactone / analogs & derivatives*
  • Spironolactone / therapeutic use
  • Young Adult

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Mineralocorticoid Receptor Antagonists
  • Sodium Chloride, Dietary
  • Spironolactone
  • Eplerenone
  • Creatine