Renal Atherosclerotic Revascularization Evaluation: RAVE Study

Hypertension, Renovascular Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127738
• Other study ID #: 216-2004
• Status: Completed
• Phase: N/A
• First received: August 4, 2005
• Last updated: January 8, 2007
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: February 2006
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension, Renovascular

Intervention

Procedure:
• Angiographic renal revascularization

Locations

Country	Name	City	State
Canada	Sunnybrook & Women's College Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dialysis
Primary	Death
Primary	Doubling of creatinine