Renal Insufficiency And Cardiovascular Events (RIACE)
Reduced glomerular filtration rate (GFR) has been recently shown to be a powerful predictor of cardiovascular morbidity and mortality in the general population, independent of traditional cardiovascular risk factors.
This observational study is aimed at assessing the association of reduced estimated GFR with cardiovascular morbidity and mortality in a large italian population (at least 15,000 subjects) of type 2 diabetic outpatients over a 4-year follow-up.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Reduced Estimated Glomerular Filtration Rate (eGFR)and Prediction of Cardiovascular Disease and Renal Outcome in Subjects With Type 2 Diabetes: Italian Multicenter Study|
- cardiovascular morbidity and mortality [ Time Frame: 4 years ]
- eGFR, as classified according to the National Kidney Foundation criteria [ Time Frame: 4 years ]
- micro/macroalbuminuria [ Time Frame: 4 years ]
- traditional cardiovascular risk factors [ Time Frame: 4 years ]
|Study Start Date:||June 2008|
|Study Completion Date:||February 2015|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Reduced GFR has been recently shown to be a powerful predictor of cardiovascular morbidity and mortality in the general population, independent of traditional cardiovascular risk factors. Since type 2 diabetic patients show increased cardiovascular morbidity and mortality as compared with the general population, the identification of predictors of cardiovascular disease in these patients is of fundamental importance for clinical purposes. One of these predictors is increased urinary albumin excretion rate, which is associated with an increased risk of cardiovascular disease more than of end-stage renal disease. However, a growing body of evidence indicates that a significant proportion of normoalbuminuric diabetic patients, particularly with type 2 diabetes, may exhibit reduced GFR. It is currently unknown the predictive role of this abnormality toward cardiovascular events and death, independent of albuminuria and other known risk factors, in the diabetic population.
This observational study is aimed at assessing the association of reduced estimated GFR with cardiovascular morbidity and mortality in a large italian population (at least 15,000 subjects) of type 2 diabetic nondialytic outpatients over a 4-year follow-up.
Secondary endpoints are to assess in this population:
- the prevalence and incidence of reduced GFR, as classified according to the National Kidney Foundation criteria, and its association with traditional cardiovascular risk factors;
- the prevalence, incidence and cardiovascular predictivity of micro and macroalbuminuria.
Patients will be recruited from electronic records of 20 italian outpatients diabetic clinics.
Routine anamnestic, clinical, laboratory and instrumental data will be recorded at baseline and over 4 years to obtain information about:
- renal function (albumin/creatinine ratio, serum creatinine with estimation of glomerular filtration rate [eGFR]);
- cardiovascular risk factors (smoking, physical activity, family history of diabetes, dyslipidemia, hypertension and cardiovascular disease, BMI and waist circumference, total, LDL, HDL and non-HDL cholesterol, triglycerides, arterial blood pressure and HbA1c);
- current glucose-, lipid- and blood pressure-lowering and anti-platelet or anti-coagulant treatment;
- other illnesses;
- cardiovascular events (myocardial infarction, stroke, lower limb ulcer/gangrene/amputation and coronary, carotid and lower limb revascularization, endovascular/surgical) and deaths.
These data will be derived from the electronic database of each participating center.
Laboratory analyses will be performed in each centre laboratory after proper standardization of analytical techniques.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715481
|Mazzoni Hospital, Division of Diabetology|
|Ascoli Piceno, Italy, 63100|
|Policlinico Hospital, Division of Endocrinology|
|Bari, Italy, 70124|
|Ospedali Riuniti di Bergamo, Division of Diabetology|
|Bergamo, Italy, 24128|
|Monserrato Hospital, Division of Diabetology|
|Cagliari, Italy, 09042|
|Mater Domini Hospital, Division of Internal Medicine|
|Catanzaro, Italy, 88100|
|Policlinico Hospital, Division of Endocrinology|
|Foggia, Italy, 71100|
|Santa Maria Goretti Hospital, Division of Diabetology|
|Latina, Italy, 04100|
|Policlinico - Maggiore Hospital, Division of Endocrinology and Diabetology|
|Milano, Italy, 20122|
|San Giuseppe Hospital, Division of Endocrinology|
|Milano, Italy, 20123|
|San Raffaele Hospital|
|Milano, Italy, 20132|
|San Paolo Hospital, Division of Internal Medicine|
|Milano, Italy, 20142|
|San Luigi Gonzaga Hospital, Division of Diabetes and Metabolic Diseases|
|Orbassano-Torino, Italy, 10043|
|Policlinico Hospital, Division of Diabetology|
|Padova, Italy, 35128|
|Cisanello Hospital, Divisions of Diabetology|
|Pisa, Italy, 56124|
|Santa Chiara Hospital, Division of Internal Medicine|
|Pisa, Italy, 56126|
|Policlinico Hospital, Division of Internal Medicine|
|Rome, Italy, 00161|
|Sant'Andrea Hospital, Division of Diabetology|
|Rome, Italy, 00189|
|Policlinico Le Scotte, Division of Diabetology|
|Siena, Italy, 53100|
|Le Molinette - San Giovanni Battista Hospital, Division of Diabetology|
|Torino, Italy, 10126|
|Maggiore Hospital, Division of Endocrinology and Metabolic Diseases|
|Verona, Italy, 37126|
|Principal Investigator:||Giuseppe Pugliese, MD, PhD||Diabetic Nephropathy Study Group|
|Study Director:||Anna Solini, MD, PhD||Diabetic Nephropathy Study Group|