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

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ClinicalTrials.gov Identifier: NCT03073018
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : March 10, 2017
Sponsor:
Collaborators:
Dutch Kidney Foundation
Netherlands Heart Foundation
Information provided by (Responsible Party):
Prof. Wiek H. van Gilst, 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.

Condition or disease Intervention/treatment Phase
Microalbuminuria Cardiovascular Diseases Renal Disease Drug: Fosinopril Drug: Pravastatin Drug: Fosinopril Placebo Drug: Pravastatin Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 864 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Renal and Vascular Endstage Disease Intervention Trial
Study Start Date : April 1998
Actual Primary Completion Date : June 2003
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fosinopril + Pravastatin
Fosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years
Drug: Fosinopril
oral administration, capsules
Other Name: Monopril

Drug: Pravastatin
oral administration, capsules
Other Name: Pravachol

Active Comparator: Fosinopril + Placebo
Fosinopril (20 mg) + pravastatin placebo once daily for 4 years
Drug: Fosinopril
oral administration, capsules
Other Name: Monopril

Drug: Pravastatin Placebo
oral administration, capsules

Active Comparator: Pravastatin + Placebo
Pravastatin (40 mg) + fosinopril placebo once daily for 4 years
Drug: Pravastatin
oral administration, capsules
Other Name: Pravachol

Drug: Fosinopril Placebo
oral administration, capsules

Placebo Comparator: Double Placebo
Fosinopril placebo and pravastatin placebo once daily for 4 years
Drug: Fosinopril Placebo
oral administration, capsules

Drug: Pravastatin Placebo
oral administration, capsules




Primary Outcome Measures :
  1. Combined incidence of all-cause mortality, MACE and/or end-stage renal disease [ Time Frame: 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 :
  1. Incidence of all-cause mortality [ Time Frame: 4 years ]
    Incidence of all-cause mortality

  2. effect of treatment on microalbuminuria [ Time Frame: 4 years ]
    albumin excretion mg/24 h

  3. effect of treatment on LDL cholesterol [ Time Frame: 4 years ]
    in mmol/L

  4. effect of treatment on blood pressure [ Time Frame: 4 years ]
    in mmHg

  5. Incidence of hospital admission [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073018


Sponsors and Collaborators
University Medical Center Groningen
Dutch Kidney Foundation
Netherlands Heart Foundation
Investigators
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Principal Investigator: Wiek H van Gilst, PhD UMCG

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Wiek H. van Gilst, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03073018     History of Changes
Other Study ID Numbers: METc 97/10/172
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Fosinopril
Cardiovascular Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents