Renal Atherosclerotic Revascularization Evaluation: RAVE Study - Full Text View

Sponsored by:	Sunnybrook Health Sciences Centre
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00127738

Purpose

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

Condition	Intervention
Hypertension, Renovascular	Procedure: Angiographic renal revascularization

MedlinePlus related topics: High Blood Pressure Vascular Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

Dialysis
Death
Doubling of creatinine

Estimated Enrollment:	240
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2006

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

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127738

Locations

Canada, Ontario
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Investigators

Principal Investigator:

Sheldon Tobe, MD

Sunnybrook & Women's College Health Sciences Centre

More Information

Publications indexed to this study:

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.

Study ID Numbers:	216-2004
Study First Received:	August 4, 2005
Last Updated:	January 8, 2007
ClinicalTrials.gov Identifier:	NCT00127738
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:

Hypertension
Renal artery stenosis
Kidney disease
Renal vascular disease
Atherosclerosis

Study placed in the following topic categories:

Hypertension, Renal
Atherosclerosis
Renal artery stenosis
Urologic Diseases
Renal hypertension

Vascular Diseases
Constriction, Pathologic
Kidney Diseases
Hypertension
Hypertension, Renovascular

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009