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Renal Atherosclerotic Revascularization Evaluation: RAVE Study

This study has been completed.
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00127738
First received: August 4, 2005
Last updated: January 8, 2007
Last verified: February 2006
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided by Sunnybrook Health Sciences Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Sunnybrook Health Sciences Centre:
Hypertension
Renal artery stenosis
Kidney disease
Renal vascular disease
Atherosclerosis

Additional relevant MeSH terms:
Hypertension
Hypertension, Renovascular
Vascular Diseases
Cardiovascular Diseases
 Hypertension, Renal
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013