A randomized, open-label single-center study investigates the efficacy and safety of bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on blood pressure and disease progression control in autosomal dominant polycystic kidney disease(ADPKD). The total number of study subjects will be 100. All of them have diagnosed with ADPKD and hypertension. Patients will be randomized 1:1 (50 with radiofrequency ablation(RFA), 50 only with drugs). Change in average office-based measurements of systolic blood pressure(SBP), average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) , incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg , office diastolic blood pressure (DBP), number and dosage of blood pressure tablets, total kidney volume (TKV), total cyst volume (TCV), pain related to cystic kidneys and renal function, will be assessed at 12 months of follow-up. The safety variables will be assessed at every visit of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
One-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation.
antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.
Department of Nephrology, Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGoffice-based measurements of systolic blood pressure
Between-group change in average office-based measurements of systolic blood pressure from baseline to 12 months after randomization and One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation.
Time frame: baseline and 12 months (day 360±14)
24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)
Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) from baseline to 12 month.
Time frame: baseline and 12 months (day 360±14)
Incidence of office systolic blood pressure reduction
Incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg from baseline to 12 month.
Time frame: baseline and 12 months (day 360±14)
office diastolic blood pressure
Change in office diastolic blood pressure from baseline to 12 months.
Time frame: baseline and 12 months (day 360±14)
number and dosage of blood pressure tablets
Change in number and dosage of blood pressure tablets from baseline to 12 months.
Time frame: baseline and 12 months (day 360±14)
estimated Glomerular Filtration Rate(eGFR)
Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.
Time frame: baseline and 12 months (day 360±14)
albuminuria
Change in albuminuria from baseline to 12 months.
Time frame: baseline and 12 months (day 360±14)
total kidney volume (TKV)
Change in total kidney volume (TKV) from baseline to 12 months
Time frame: baseline and 12 months (day 360±14)
pain
Change in pain related to cystic kidneys from baseline to 12 months.
Time frame: baseline and 12 months (day 360±14)
procedure-related complications at femoral puncture site
Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).
Time frame: up to 1 year (after radiofrequency ablation)
Renal artery lesion
Renal artery lesion (perforation or dissection).
Time frame: up to 1 year (after radiofrequency ablation)
New renal artery stenosis
New renal artery stenosis \>70%, determined by MRI within 12 months of randomization.
Time frame: up to 1 year (after radiofrequency ablation)
Embolic events
Embolic events.
Time frame: up to 1 year (after radiofrequency ablation)
hypotension
Episodes of hypotension.
Time frame: up to 1 year (after radiofrequency ablation)
hypertension.
Episodes of hypertension.
Time frame: up to 1 year (after radiofrequency ablation)
acute kidney injury
Acute deterioration of renal function
Time frame: up to 1 year (after radiofrequency ablation)
total cyst volume (TCV)
Change in total cyst volume (TCV) from baseline to 12 months
Time frame: baseline and 12 months (day 360±14)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.