Prevention of Renal and Vascular Endstage Disease Intervention Trial

NCT03073018 | Completed Phase 3

• 1 other identifier: METc 97/10/172
• Study Type: interventional
• Target: 864
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Microalbuminuria; Cardiovascular Diseases; Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of all-cause mortality

  4 years

• effect of treatment on microalbuminuria

  4 years

• effect of treatment on LDL cholesterol

  4 years

• effect of treatment on blood pressure

  4 years

• Incidence of hospital admission

  4 years

Study Arms (4)

Fosinopril + Pravastatin

EXPERIMENTAL

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

Drug: Fosinopril; Drug: Pravastatin

Fosinopril + Placebo

ACTIVE COMPARATOR

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

Drug: Fosinopril; Drug: Pravastatin Placebo

Pravastatin + Placebo

ACTIVE COMPARATOR

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

Drug: Pravastatin; Drug: Fosinopril Placebo

Double Placebo

PLACEBO COMPARATOR

Fosinopril placebo and pravastatin placebo once daily for 4 years

Drug: Fosinopril Placebo; Drug: Pravastatin Placebo

Interventions

Fosinopril DRUG

oral administration, capsules

Also known as: Monopril

Fosinopril + Placebo; Fosinopril + Pravastatin

Pravastatin DRUG

oral administration, capsules

Also known as: Pravachol

Fosinopril + Pravastatin; Pravastatin + Placebo

Fosinopril Placebo DRUG

oral administration, capsules

Double Placebo; Pravastatin + Placebo

Pravastatin Placebo DRUG

oral administration, capsules

Double Placebo; Fosinopril + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Dutch Kidney Foundation: collaborator
• Netherlands Heart Foundation: collaborator

Related Publications (3)

• 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. doi: 10.1016/s0002-9149(00)01042-0.

  PMID: 10980214 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000146378.65439.7A. Epub 2004 Oct 18.

  PMID: 15492322 BACKGROUND

• Kofink D, Eppinga RN, van Gilst WH, Bakker SJL, Dullaart RPF, van der Harst P, Asselbergs FW. Statin Effects on Metabolic Profiles: Data From the PREVEND IT (Prevention of Renal and Vascular End-stage Disease Intervention Trial). Circ Cardiovasc Genet. 2017 Dec;10(6):e001759. doi: 10.1161/CIRCGENETICS.117.001759.

  PMID: 29237679 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Kidney Diseases

Interventions

Fosinopril; Pravastatin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphinic Acids; Organophosphorus Compounds; Organic Chemicals; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Wiek H van Gilst, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: March 8, 2017
• Study Start: April 1, 1998
• Primary Completion: June 1, 2003
• Study Completion: November 1, 2003
• Last Updated: March 10, 2017

Record last verified: 2017-03