Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND-IT)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 3

Conditions: Microalbuminuria; Cardiovascular Diseases; Renal Disease

Treatments: Drug: Fosinopril; Drug: Pravastatin; Drug: Fosinopril Placebo; Drug: Pravastatin Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03073018

METc 97/10/172

Details and patient eligibility

About

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.

Full description

This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/ day will prevent cardiovascular and renal disease in nonhypertensive (RR <160/100 mm Hg and not using antihypertensive medication) and nonhypercholesterolemic (total cholesterol <8.0 or <5.0 mmol/L in case of previous myocardial infarction and not using lipid lowering medication) men and women with persistent microalbuminuria (urinary albumin excretion >10 mg/L once in an early morning spot urine and 15 to 300 mg/24-hour at least once in two 24-hour urine collections). The Prevention of REnal and Vascular ENdstage Disease Intervention Trial is a single-center, double-blind, randomized, placebo-controlled trial with a 2 x 2 factorial design. The 864 randomized subjects will be monitored for a minimum of 4 years and a maximum of 5 years. The primary efficacy parameter is defined as the combined incidence of all-cause mortality or hospital admission for documented (1) nonfatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease.

Enrollment: 864 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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864 participants in 4 patient groups, including a placebo group

Fosinopril + Pravastatin

Experimental group

Description:

Fosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years

Treatment:

Drug: Pravastatin

Drug: Fosinopril

Fosinopril + Placebo

Active Comparator group

Description:

Fosinopril (20 mg) + pravastatin placebo once daily for 4 years

Treatment:

Drug: Fosinopril

Drug: Pravastatin Placebo

Pravastatin + Placebo

Active Comparator group

Description:

Pravastatin (40 mg) + fosinopril placebo once daily for 4 years

Treatment:

Drug: Pravastatin

Drug: Fosinopril Placebo

Double Placebo

Placebo Comparator group

Description:

Fosinopril placebo and pravastatin placebo once daily for 4 years

Treatment:

Drug: Fosinopril Placebo

Drug: Pravastatin Placebo