Hypertension, Renovascular
Conditions
Keywords
Hypertension, Renal artery stenosis, Kidney disease, Renal vascular disease, Atherosclerosis
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.
Interventions
PROCEDUREAngiographic renal revascularization
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dialysis | — |
| Death | — |
| Doubling of creatinine | — |
Countries
Canada
Outcome results
None listed