Patients with one or more cardiovascular risk factors and microalbuminuria, diabetic or not diabetic. MedDRA version: 9.1 Level: LLT Classification code 10027525 Term: Microalbuminuria
Conditions
Interventions
Pharmaceutical Form: Tablet
Concentration type: equal
Pharmaceutical Form: Tablet
Concentration type: equal
Pharmaceutical Form: Tablet
Other descriptive name: association one drug of the ATC class
Sponsors
CONSORZIO MARIO NEGRI SUD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signing and informed consent Presence of micro/macroalbuminuria already known or detected by measurement of albumin creatinine ration on a morning urine spot in 2 separate occasion, after excluding coexisting causes of increased urine albumin excretion by patient interview and urinary dipstick One or more cardiovascular risk factors Cigarette smoking; Type 1 or 2 diabetes; Hypertension; Visceral obesity; Hypercholesterolemia; Family history of cardiovascular disease. Individuals who have previously presented a major cardio-cerebrovascular event coronary heart disease, non fatal stroke, hospitalization for any cardiovascular cause may be enrolled in the trial provided this event has occurred at least 6 months before enrolment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant women Women who intend to become pregnant throughout the 4 years from enrolment to end of study Neoplasia within up to 5 years from assessment of eligibility for study excluding skin cell basalioma Clinically significant aortic obstruction Clear contraindications to use of RAS inhibitors Any condition which significantly reduces life expectancy Non compliant patient .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate comparative efficacy for cardiac and cerebro-vascular outcomes of combined therapy with ACEi and ARB versus monotherapy with ACEi or ARB in patients at cardio-renal risk.;Secondary Objective: To evaluate comparative efficacy for cardiac and cerebrovascular outcomes of ACEi monotherapy versus ARB monotherapy in individuals with cardio-renal risk; To evaluate comparative efficacy for renal outcomes of ACEi/ARB/combined treatment of ACEi ARB in the same individuals with cardio-renal risk.;Primary end point(s): One of the following events Cardiovascular mortality; Coronary heart disease; Non fatal stroke; Hospitalization for any cardiovascular cause. | — |
Countries
Italy
Outcome results
None listed