RecruitingPhase 3ACTRN12607000333415

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.


Sponsor

Consorzio Mario Negri Sud

Enrollment

2,100 participants

Start Date

Nov 22, 2007

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether combining two types of blood pressure and kidney-protecting medicines — an ACE inhibitor and an angiotensin receptor blocker (ARB) — works better than using just one of them alone. The study is for people who have high levels of protein in their urine (which signals kidney stress) and at least one risk factor for heart disease. The goal is to see if combination therapy can better protect the heart and kidneys over the long term. You may be eligible if: - You are 18 years of age or older - You have high levels of protein in your urine (microalbuminuria or macroalbuminuria) - You have one or more cardiovascular risk factors (such as smoking, diabetes, high blood pressure, obesity, high cholesterol, or a family history of heart disease) - If you have had a previous heart attack or stroke, it must have been at least 6 months ago You may NOT be eligible if: - You are pregnant or not using contraception - You have been diagnosed with cancer - You have severe narrowing of the aorta - You have had an allergic or adverse reaction to the study medicines - You have had a major cardiovascular event in the last 6 months - You have a condition that significantly reduces life expectancy Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 A

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)

Italy

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ACTRN12607000333415