NCT01932450

Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control

A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mei changlin · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Autosomal Dominant Polycystic Kidney Disease
• Hypertension

Interventions

Type	Name	Description
PROCEDURE	renal sympathetic denervation	One-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation.
DRUG	antihypertensive drugs	antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-12-01
• Completion: 2015-07-01
• First posted: 2013-08-30
• Last updated: 2014-09-25

Locations

1 site across 1 country: China