Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe Atherosclerotic Renal Artery Stenosis Undergoing Stent Placement

Blood Pressure Clinical Trial

Official title:

A Prospective, Randomized Trial to Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe Atherosclerotic Renal Artery Stenosis Undergoing Stent Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521700
• Other study ID #: 2014-ZX13
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1, 2013
• Est. completion date: December 30, 2015

Study information

• Verified date: May 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 30, 2015
• Est. primary completion date: December 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Blood Pressure
• Glomerular Filtration Rate
• Lipids
• Renal Artery Obstruction
• Stents

Intervention

Drug:
• Rosuvastatin
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.

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in estimated glomerular filtration rate		12 months after randomization
Secondary	Change in urinary albumin-creatinine ratio		12 months after randomization
Secondary	Change in the number of antihypertensive medications		12 months after randomization
Secondary	Change in systolic blood pressure		12 months after randomization
Secondary	Change in diastolic blood pressure		12 months after randomization
Secondary	Stent restenosis rate		12 months after randomization
Secondary	Major clinical events	death from cardiovascular or renal causes, myocardial infarction, hospitalization for congestive heart failure, stroke, and a relative increase in SCr from baseline of =50%	12 months after randomization