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Renal Atherosclerotic Revascularization Evaluation: RAVE Study

This study has been completed.
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00127738
First received: August 4, 2005
Last updated: January 8, 2007
Last verified: February 2006
History of Changes

August 4, 2005
January 8, 2007
January 2005
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  • Dialysis
  • Death
  • Doubling of creatinine
Same as current
Complete list of historical versions of study NCT00127738 on ClinicalTrials.gov Archive Site
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Renal Atherosclerotic Revascularization Evaluation: RAVE Study
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The RAVE study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.

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.
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension, Renovascular
Procedure: Angiographic renal revascularization
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
December 2006
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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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00127738
216-2004
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Sunnybrook Health Sciences Centre
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Principal Investigator: Sheldon Tobe, MD Sunnybrook & Women's College Health Sciences Centre
Sunnybrook Health Sciences Centre
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP