Rationale and design of a large study to evaluate the renal and cardiovascular effects of an ACE inhibitor and vitamin E in high-risk patients with diabetes. The MICRO-HOPE Study. Microalbuminuria, cardiovascular, and renal outcomes. Heart Outcomes Prevention Evaluation.
OBJECTIVE
To describe the rationale and design of a large international study (microalbuminuria, cardiovascular, and renal outcomes [MICRO] in the HOPE [Heart Outcomes Prevention Evaluation] study) of an ACE inhibitor and vitamin E for the prevention of diabetic nephropathy (DN) and cardiovascular disease (CVD) in patients with diabetes and microalbuminuria (MA).


METHODS
A total of 3,657 diabetic subjects, including 1,129 with MA, are randomly allocated to receive the ACE inhibitor ramipril (or placebo) and vitamin E (or placebo) for 4 years in a two-by-two factorial design. Diabetic subjects are a subset of the 9,541 subjects enrolled in the HOPE study.


RESULTS
The development of DN in microalbuminuric diabetic subjects and the development of MA in normoalbuminuric subjects, as well as cardiovascular death, myocardial infarction, and storke, are the main outcomes. The correlation of changes in albuminuria with changes in carotid atherosclerosis documented in a subset of subjects will also be analyzed.


CONCLUSIONS
The effect of both an ACE inhibitor and vitamin E on the progression of renal and CVD in patients with diabetes is being assessed in the MICRO-HOPE study.
Gerstein
H C
HC
McMaster University, Hamilton, Ontario, Canada. gerstein@fhs.csu.mcmaster.ca
Bosch
J
J
Pogue
J
J
Taylor
D W
DW
Zinman
B
B
Yusuf
S
S
D000419:Albuminuria; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000503:physiopathology; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000503:physiopathology; D003925:Diabetic Angiopathies / Q000517:prevention & control*; D003928:Diabetic Nephropathies / Q000453:epidemiology / Q000517:prevention & control*; D005163:Factor Analysis, Statistical; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D017257:Ramipril / Q000627:therapeutic use*; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D014810:Vitamin E / Q000627:therapeutic use*
D000806:Angiotensin-Converting Enzyme Inhibitors; D010919:Placebos; D014810:Vitamin E; D017257:Ramipril