Renal Atherosclerotic Revascularization Evaluation: RAVE Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Hypertension, Renovascular

Intervention / Treatment
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* Procedure: Angiographic renal revascularization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Angiographic renal revascularization|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis |  |  | 
| Death |  |  | 
| Doubling of creatinine |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Renal artery stenosis, Kidney disease, Renal vascular disease, Atherosclerosis