Prevention of Renal and Vascular Endstage Disease Intervention Trial

Cardiovascular Diseases Clinical Trial

— PREVEND-IT  

Official title:

Prevention of Renal and Vascular Endstage Disease Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073018
• Other study ID #: METc 97/10/172
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2017
• Last updated: March 7, 2017
• Start date: April 1998
• Est. completion date: November 2003

Study information

• Verified date: March 2017
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 864
• Est. completion date: November 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Microalbuminuria
• Renal Disease

Intervention

Drug:
• Fosinopril
oral administration, capsules
• Pravastatin
oral administration, capsules
• Fosinopril Placebo
oral administration, capsules
• Pravastatin Placebo
oral administration, capsules

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	Dutch Kidney Foundation, Netherlands Heart Foundation

References & Publications (2)

Asselbergs FW, Diercks GF, Hillege HL, van Boven AJ, Janssen WM, Voors AA, de Zeeuw D, de Jong PE, van Veldhuisen DJ, van Gilst WH; Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) Investigators.. Effects of fosinopril and pravastatin on cardiovascular events in subjects with microalbuminuria. Circulation. 2004 Nov 2;110(18):2809-16. — View Citation

Diercks GF, Janssen WM, van Boven AJ, Bak AA, de Jong PE, Crijns HJ, van Gilst WH. Rationale, design, and baseline characteristics of a trial of prevention of cardiovascular and renal disease with fosinopril and pravastatin in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria (the Prevention of REnal and Vascular ENdstage Disease Intervention Trial [PREVEND IT]). Am J Cardiol. 2000 Sep 15;86(6):635-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined incidence of all-cause mortality, MACE and/or end-stage renal disease	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	4 years
Secondary	Incidence of all-cause mortality	Incidence of all-cause mortality	4 years
Secondary	effect of treatment on microalbuminuria	albumin excretion mg/24 h	4 years
Secondary	effect of treatment on LDL cholesterol	in mmol/L	4 years
Secondary	effect of treatment on blood pressure	in mmHg	4 years
Secondary	Incidence of hospital admission	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	4 years