Renal Atherosclerotic Revascularization Evaluation: RAVE Study

Overview

The RAVE study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

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.

Interventions

  • Procedure: Angiographic renal revascularization

Clinical Trial Outcome Measures

Primary Measures

  • Dialysis
  • Death
  • Doubling of creatinine

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sunnybrook Health Sciences Centre
  • Overall Official(s)
    • Sheldon Tobe, MD, Principal Investigator, Sunnybrook & Women’s College Health Sciences Centre

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