Prevention of Renal and Vascular Endstage Disease Intervention Trial

Phase 3

Completed

• Conditions: Microalbuminuria; Renal Disease; Cardiovascular Diseases
• Interventions: Drug: Fosinopril; Drug: Pravastatin; Drug: Pravastatin Placebo; Drug: Fosinopril Placebo

• Registration Number: NCT03073018
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1998-04
• Primary Completion: 2003-06
• Study Completion: 2003-11
• Study First Submitted: 2017-01-27
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-07
• Study First Posted: 2017-03-08
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 864

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Fosinopril + Pravastatin	Pravastatin	Fosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years
Fosinopril + Pravastatin	Fosinopril	Fosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years
Fosinopril + Placebo	Fosinopril	Fosinopril (20 mg) + pravastatin placebo once daily for 4 years
Fosinopril + Placebo	Pravastatin Placebo	Fosinopril (20 mg) + pravastatin placebo once daily for 4 years
Pravastatin + Placebo	Pravastatin	Pravastatin (40 mg) + fosinopril placebo once daily for 4 years
Pravastatin + Placebo	Fosinopril Placebo	Pravastatin (40 mg) + fosinopril placebo once daily for 4 years
Double Placebo	Fosinopril Placebo	Fosinopril placebo and pravastatin placebo once daily for 4 years
Double Placebo	Pravastatin Placebo	Fosinopril placebo and pravastatin placebo once daily for 4 years

Primary Outcome Measures

Name	Time	Method
Combined incidence of all-cause mortality, MACE and/or end-stage renal disease	4 years	Combined incidence of all-cause mortality or hospital admission for documented (1) non-fatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease

Secondary Outcome Measures

Name	Time	Method
Incidence of hospital admission	4 years	Incidence of hospital admission for documented (1) non-fatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease
Incidence of all-cause mortality	4 years	Incidence of all-cause mortality
effect of treatment on microalbuminuria	4 years	albumin excretion mg/24 h
effect of treatment on LDL cholesterol	4 years	in mmol/L
effect of treatment on blood pressure	4 years	in mmHg