CompletedPhase 3

Prevention of Renal and Vascular Endstage Disease Intervention Trial

864 participantsStarted 1998-04

Plain-language summary

The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was designed to determine whether intervention with the angiotensin-converting enzyme (ACE) inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor pravastatin reduced cardiovascular and renal events in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Persistent microalbuminuria (urinary albumin excretion \>10mg/L once in an early morning spot urine and 15 to 300 mg/24 hours at least once in two 24-hour urine samples) * No hypertension (RR \<160/100 mm Hg, no anti-hypertensive medication) * No hypercholesterolemia (total cholesterol \<8.0 or \<5.0 mmol/L in case of previous myocardial infarction and not using lipid-lowering medication) Exclusion Criteria: * Creatinine clearance \>60% of the normal age-adjusted value * Serum potassium \>5.5 mmol/L * History of chronic liver disease * Lactate dehydrogenase, aspartate-amino transferase or alanine-amino transferase \>3 times the upper limit of normal * Use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists * Use of insulin * Previously documented allergy or intolerance to study drugs * Pregnant or nursing women

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Combined incidence of all-cause mortality, MACE and/or end-stage renal disease

Timeframe: 4 years

Trial details

NCT IDNCT03073018

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2003-06

View on ClinicalTrials.gov More Microalbuminuria trials