The non-insulin-dependent diabetes, hypertension, microalbuminuria or proteinuria, cardiovascular events, and ramipril (DIABHYCAR) study: Design, organization, and patient recruitment

Controlled Clinical Trials

Volumn 21, Issue 4, 2000, Pages 383-396

  Lièvre, Michel ^a   Marre, Michel ^b   Chatellier, Gilles ^c   Plouin, Pierre François ^c   Réglier, Jean Christophe ^d   Richardson, Linda ^e   Bugnard, Françoise ^a   Vasmant, Daniel ^d  

^a Department of Clinical Pharmacology ^*  (France)

^b ANGERS UNIVERSITY HOSPITAL   (France)

^c HÔPITAL BROUSSAIS   (France)

^d SANOFI   (France)

^e DIABHYCAR Subcoordinating Ctr Eur   (United Kingdom)

Author keywords

Cardiovascular diseases; Diabetes mellitus; Ramipril; Randomized controlled trial

Indexed keywords

DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; PLACEBO; RAMIPRIL;

ADULT; CARDIOVASCULAR DISEASE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DOUBLE BLIND PROCEDURE; FRANCE; GENERAL PRACTITIONER; HEART INFARCTION; HEMODIALYSIS; HIGH RISK POPULATION; HUMAN; HYPERTENSION; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; METHODOLOGY; MICROALBUMINURIA; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; ORGANIZATION; OUTCOMES RESEARCH; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; SHORT SURVEY; STROKE; SUDDEN DEATH;

EID: 0343060965     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(00)00060-X     Document Type: Article

References (26)

1. Kannel W.B., McGee D.L. Diabetes and cardiovascular risk factors. The Framingham Study. Circulation. 59:1979;8-13.
2. Stamler J., Vaccaro O., Neaton J.D., Wentworth D., for the Multiple Risk Factor Intervention Trial Research Group Diabetes, other risk factors and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diab Care. 16:1993;434-444.
3. Mogensen C.E. Microalbuminuria predicts clinical proteinuria and early mortality in maturity onset diabetes. N Engl J Med. 310:1984;356-360.
4. Neil A., Hawkins M., Potok M.et al. A prospective population-based study of microalbuminuria as a predictor of mortality in NIDDM. Diab Care. 16:1993;996-1003.
5. Mattock M.B., Morrish N.J., Viberti G.C.et al. Prospective study of microalbuminuria as predictor of mortality in NIDDM. Diabetes. 41:1992;736-741.
6. MacLeod J.M., Lutale J., Marshall S.M. Albumin excretion and vascular deaths in NIDDM. Diabetologia. 38:1995;610-616.
7. Stiegler H., Standl E., Schulz K.et al. Morbidity, mortality, and albuminuria in type 2 diabetic patients. A three-year prospective study of a random cohort in general practice Diab Med. 9:1993;646-653.
8. Ravid M., Savin H., Jutrini I.et al. Long-term stabilizing effect of angiotensin converting enzyme inhibition on plasma creatinine and on proteinuria in normotensive type II diabetic patients. Ann Intern Med. 118:1993;577-581.
9. Lebovitz H.E., Wiegmann T.B., Cnaan A.et al. Renal protective effects of enalapril in hypertensive NIDDM. Role of baseline albuminuria. Kidney Int. 45(suppl):1994;S150-S155.
10. Pfeffer M.A. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial N Engl J Med. 322:1992;669-677.
11. Yusuf S. Effect of enalapril on myocardial infarction and unstable angina in patients with low ejection fraction. Lancet. 340:1992;1173-1178.
12. Effects of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure. Lancet. 342:1993;821-828.
13. Schmieder R.E., Martus P., Klingbeil A. Reversal of left ventricular hypertrophy in essential hypertension. A meta-analysis of randomized double-blind studies. JAMA. 275:1996;1507-1513.
14. Marre M., Hallab M., Billard A.et al. Small doses of ramipril to reduce microalbuminuria in diabetic patients with incipient nephropathy independently of blood pressure changes. J Cardiovasc Pharmacol. 18(suppl 2):1991;S165-S168.
15. Lièvre M., Guéret P., Gayet D.et al. Ramipril-induced regression of left ventricular hypertrophy in treated hypertensive individuals. Hypertension. 25:1995;92-97.
16. The HOPE (Heart Outcomes Prevention Evaluation) Study. The design of a large, simple randomized trial of an angiotensin-converting enzyme inhibitor (ramipril) and vitamin E in patients at high risk of cardiovascular events Can J Cardiol. 12:1996;127-137.
17. Hypertension in Diabetes Study. I. Prevalence of hypertension in newly presenting type 2 diabetic patients and the association with risk factors for cardiovascular and diabetic complications J Hypertens. 11:1993;309-317.
18. Hypertension in Diabetes Study. II. Increased risk of cardiovascular complications in hypertensive type 2 diabetic patients J Hypertens. 11:1993;319-325.
19. Aspirin effects on mortality and morbidity in patients with diabetes mellitus. Early Treatment Diabetic Retinopathy Study Report 14. JAMA. 268:1992;1292-1300.
20. Marre M., Girault A., Vasmant D.et al. Prévalence de la microalbuminurie chez les diabétiques de type 2 français suivis par leur médecin généraliste. Diab Metab. 21:1995;34-40.
21. Passa P., Chatellier G., on behalf of the DIABHYCAR Study Group The DIABHYCAR Study. Diabetologia. 39:1996;1662-1667.
22. Marre M., Claudel J.P., Ciret P.et al. Laser immunophelometry for routine quantification of urinary albumin excretion. Clin Chem. 33:1987;209-214.
23. Bouhanick B., Berrut G., Chameau D.et al. Predictive value of testing random urine samples to detect microalbuminuria in diabetic subjects during outpatient visit. Diab Metab. 18:1992;54-58.
24. Marre M., Lièvre M., Vasmant D.et al. Determinants of elevated urinary albumin in 25 455 type 2 diabetic subjects in Western Europe and North Africa. Recruitment phase of the DIABHYCAR study Diab Care. 23(Suppl 2):2000;1340.
25. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus. Results of the HOPE study and MICRO-HOPE substudy Lancet. 355:2000;253-259.
26. Renaud S., De Lorgeril M. Wine, alcohol, platelets, and the French paradox for coronary heart disease. Lancet. 339:1992;1523-1526.