Long 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.
In patients with one or more cardiovascular risk factors and microalbuminuria, diabetic or not diabetic, administration of angiotensin converting enzyme inhibitors, angiotensin receptor blockers or combined therapy with both agents, comparison of three arms to assess the impact on cardiovascular and cerebrovascular outcomes.
Consorzio Mario Negri Sud
2,100 participants
Nov 22, 2007
Interventional
Conditions
Summary
Approved without conditions. People with high urinary albumin level has a higher risk of cardiovascular diseases than other people. The aim of the study is to clarify if it is possible to further reduce the renal- and cardiovascular diseases risk using ACE-inhibitors and angiotensin receptor blockers instead of using only ACE-inhibitors or only angiotensin receptor blockers.
Eligibility
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Interventions
ACE-inhibitor (ACEi) monotherapy or angiotensin II receptor blocker (ARB) monotherapy or combined treatment with ACEi + ARB. Physicians will able to choose any commercially available ACEi or ARB of ACEi or ARB commercially available provided a blood pressure target of <130/80 mmHg is addressed. The dose depends on the drug(s) selected by the investigator; the administration is by mouth (per os). Duration of intervention/s: daily for the duration of the trial (4 years). It is not possible to define a standard dose: the randomization decides which drug class will be assigned; the investigators must choose one of the drugs included in the class. The dose will be the standard dose of the selected drug. Therefore as the investigators can choose among about 85 ACEi and 36 ARB, it is not possible to define a standard dose.
Locations(1)
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ACTRN12607000333415