Blood Pressure, Glomerular Filtration Rate, Lipids, Renal Artery Obstruction, Stents
Conditions
Keywords
Renal Artery Obstruction, Stents, Glomerular filtration rate
Brief summary
Although expert consensuses recommend the use of statins in the treatment of atherosclerotic renal artery stenosis, in patients with severe atherosclerotic renal artery stenosis undergoing stent placement, the related investigation focused on renal protection by intensive lipid-lowering therapy is scant , and the optimal target level for lipid reduction remain uncertain. Therefore, we hypothesized that intensive lipid lowering could offer more benefits with respect to renal function in the patients with percutaneous renal artery stenting. We conducted the prospective randomized unblinded trial to compare the renal-protective effect of intensive lipid lowering with that of conventional lipid lowering in patients underwent renal artery stenting (75 patients in each study group)
Interventions
DRUGRosuvastatin
For patients who were assigned to receive intensive lipid lowering, 10 mg/d rosuvastatin was initially prescribed and target LDL-C was \< 1.8mmol/L. For patients who were assigned to receive conventional lipid lowering, 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, \<3.3mmol/L.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intensive lipid lowering gourp:10 mg/d rosuvastatin was initially prescribed and target LDL-C was \< 1.8mmol/L; Conventional lipid lowering: 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, \<3.3mmol/L
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Angiographic evidence of severe atherosclerotic renal artery stenosis (diameter reduction≥ 70%) with ≥ 20 mmHg systolic translesional gradient or positive captopril renography in the target kidney; 2. Sustained systolic blood pressure ≥ 180 mmHg, and/or diastolic blood pressure ≥ 110 mmHg while not receiving drug therapy or systolic blood pressure ≥ 140 mmHg, and/or diastolic blood pressure ≥ 90mmHg while taking standard triple-drug combination treatment (including one diuretic); 3. Estimated glomerular filtration rate≥ 10 ml/min/1.73m2 with longitudinal kidney length ≥ 7 cm supplied by target artery; 4. Serum creatinine level\<264umol/L； 5. Urine protein≤ 1+
Exclusion criteria
1. Allergy to rosuvastatin; 2. Myopathy; 3. Active liver disease or alanine aminotransferase and/or aspartate aminotransferase levels ≥ three times the upper limit of normality; 4. Serious perioperative complications; 5. Severe chronic congestive heart failure (New York Heart Association functional class IV ); 6. Patients who should be excluded basing on physician discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in estimated glomerular filtration rate | 12 months after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of antihypertensive medications | 12 months after randomization | — |
| Change in systolic blood pressure | 12 months after randomization | — |
| Change in urinary albumin-creatinine ratio | 12 months after randomization | — |
| Stent restenosis rate | 12 months after randomization | — |
| Major clinical events | 12 months after randomization | death from cardiovascular or renal causes, myocardial infarction, hospitalization for congestive heart failure, stroke, and a relative increase in SCr from baseline of ≥50% |
| Change in diastolic blood pressure | 12 months after randomization | — |
Countries
China
Outcome results
None listed