Clinical trial NCT00127738: Renal Atherosclerotic Revascularization Evaluation: RAVE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Renovascular
Keywords: Hypertension
Renal artery stenosis
Kidney disease
Renal vascular disease
Atherosclerosis
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2005-08-08
Enrollment: 240
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dialysis
measure: Death
measure: Doubling of creatinine
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook & Women's College Health Sciences Centre
name: Sheldon Tobe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.