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Renal Atherosclerotic Revascularization Evaluation: RAVE Study

Primary Purpose

Hypertension, Renovascular

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Angiographic renal revascularization
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Renovascular focused on measuring Hypertension, Renal artery stenosis, Kidney disease, Renal vascular disease, Atherosclerosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg despite at least 3 antihypertensive medications Systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg on two antihypertensives with: a rise in creatinine > 20% after initiation of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB); the sudden onset of hypertension occurring after age 55; hypokalemia or the presence of an abdominal bruit; a history of flash pulmonary edema; or any three of: peripheral vascular disease, coronary artery disease, cerebrovascular disease, smoking, hyperlipidemia, diabetes or male gender. Exclusion Criteria: Serum creatinine > 220 umol/L or estimated glomerular filtration rate (GFR) by Cockroft-Gault equation < 20 ml/min Patients who are unwilling or unable to give informed consent Known contraindication to renal revascularization such as anaphylactic allergy to contrast dye An abdominal aortic aneurysm requiring surgery A single functioning kidney; a total occlusion of the renal artery or renal artery stenosis due to fibromuscular dysplasia. Previous revascularization

Sites / Locations

  • Sunnybrook & Women's College Health Sciences Centre

Outcomes

Primary Outcome Measures

Dialysis
Death
Doubling of creatinine

Secondary Outcome Measures

Full Information

First Posted
August 4, 2005
Last Updated
January 8, 2007
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00127738
Brief Title
Renal Atherosclerotic Revascularization Evaluation: RAVE Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

5. Study Description

Brief Summary
The RAVE study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.
Detailed Description
It is uncertain whether patients with renal vascular disease will have renal or mortality benefits from re-establishing renal blood flow with renal revascularization procedures. Patients will be assessed for the standard nephrology research outcomes of progression to doubling of creatinine, need for dialysis, and death, as well as other cardiovascular outcomes. The investigators will also establish whether the use of a new inexpensive, simple and available ultrasound test, the renal resistance index (RRI), can identify patients with renal vascular disease who will not benefit from renal revascularization procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Renovascular
Keywords
Hypertension, Renal artery stenosis, Kidney disease, Renal vascular disease, Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Angiographic renal revascularization
Primary Outcome Measure Information:
Title
Dialysis
Title
Death
Title
Doubling of creatinine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg despite at least 3 antihypertensive medications Systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg on two antihypertensives with: a rise in creatinine > 20% after initiation of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB); the sudden onset of hypertension occurring after age 55; hypokalemia or the presence of an abdominal bruit; a history of flash pulmonary edema; or any three of: peripheral vascular disease, coronary artery disease, cerebrovascular disease, smoking, hyperlipidemia, diabetes or male gender. Exclusion Criteria: Serum creatinine > 220 umol/L or estimated glomerular filtration rate (GFR) by Cockroft-Gault equation < 20 ml/min Patients who are unwilling or unable to give informed consent Known contraindication to renal revascularization such as anaphylactic allergy to contrast dye An abdominal aortic aneurysm requiring surgery A single functioning kidney; a total occlusion of the renal artery or renal artery stenosis due to fibromuscular dysplasia. Previous revascularization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon Tobe, MD
Organizational Affiliation
Sunnybrook & Women's College Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook & Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17257413
Citation
Tobe SW, Atri M, Perkins N, Pugash R, Bell CM. Renal athersosclerotic revascularization evaluation (RAVE study): study protocol of a randomized trial [NCT00127738]. BMC Nephrol. 2007 Jan 26;8:4. doi: 10.1186/1471-2369-8-4.
Results Reference
derived

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Renal Atherosclerotic Revascularization Evaluation: RAVE Study

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