Renal Atherosclerotic Revascularization Evaluation: RAVE Study

NCT00127738 | Completed

• 1 other identifier: 216-2004
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Renovascular

Keywords

Hypertension; Renal artery stenosis; Kidney disease; Renal vascular disease; Atherosclerosis

Outcome Measures

Primary Outcomes (3)

• Dialysis

• Death

• Doubling of creatinine

Interventions

Angiographic renal revascularization PROCEDURE

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 17257413 DERIVED

MeSH Terms

Conditions

Hypertension, Renovascular; Hypertension; Renal Artery Obstruction; Kidney Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Hypertension, Renal; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Arteriosclerosis

Study Officials

• Sheldon Tobe, MD

  Sunnybrook & Women's College Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2005
• First Posted: August 8, 2005
• Study Start: January 1, 2005
• Study Completion: December 1, 2006
• Last Updated: January 11, 2007

Record last verified: 2006-02

Locations

CA (1)