None listed
Conditions
Brief 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.
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 de
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.
Sponsors
Consorzio Mario Negri Sud
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed