ong term impact of RAS inhibition on cardio-renal outcomes: a comparative trial of angiotensin converting enzyme inhibitors, angiotensin receptor blockers or combined therapy with both agents in patients with one or more cardiovascular risk factors and microalbuminuria, diabetic or not diabetic.

Phase 3

Recruiting

• Conditions: Patients with one or more cardiovascular risk factors and microalbuminuria, diabetic or not diabetic.; Cardiovascular - Normal development and function of the cardiovascular system; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12607000333415
• Lead Sponsor: Consorzio Mario Negri Sud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

Consenting individuals, with microalbuminuria or macroalbuminuria, with one or more cardiovascular risk factors (smoking, diabetes, hypertension, visceral obesity, dyslipidemia, family history of cardiovascular diseases) including those with previous major cardiovascular events provided these have occurred at least 6 months before enrolment.

Exclusion Criteria

Pregnancy, no use of birth control measures, neoplasm, clinically significant aortic obstruction, previous evidence of intolerance to study medications, clear contraindications to use of RAS inhibition, major cardiovascular events within 6 months of randomization, any condition which significantly reduces life expectancy and any condition where the patient appears not to be able to guarantee compliance with treatment and follow-up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the comparative efficacy for cardiovascular and cerebrovascular outcomes of combined therapy with angiotensin converting enzyme inhibitors (ACEi) and (angiotensin receptor blockers) ARB versus monotherapy with ACEi or ARB in individuals with micro/macroalbuminuria and cardio-renal risk.[Every follow up visit (1, 3 and 6 months after randomization and then every six months).];To evaluate the comparative efficacy for cardiac and cerebrovascular outcomes of ACEi monotherapy versus ARB monotherapy in the same individuals with micro/macroalbuminuria and cardio-renal risk.[Every follow up visit (1, 3 and 6 months after randomization and then every six months).]

Secondary Outcome Measures

Name	Time	Method
To evaluate the comparative efficacy for renal outcomes of combined therapy with angiotensin converting enzyme inhibitors (ACEi) and (angiotensin receptor blockers) ARB versus monotherapy with ACEi or ARB in individuals with micro/macroalbuminuria and cardio-renal risk.[Every follow up visit (1, 3 and 6 months after randomization and then every six months).];To evaluate the comparative efficacy for renal outcomes of ACEi monotherapy versus ARB monotherapy in the same individuals with micro/macroalbuminuria and cardio-renal risk.[Every follow up visit (1, 3 and 6 months after randomization and then every six months).]