Ignite Creation Date:
2024-05-06 @ 1:58 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01932450
Status:
UNKNOWN
Last Update Posted:
2014-09-25
First Post:
2013-08-18
Brief Title:
Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control
Sponsor:
Mei changlin
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
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
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAFALE
Brief 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 diseaseADPKD The total number of study subjects will be 100 All of them have diagnosed with ADPKD and hypertension Patients will be randomized 11 50 with radiofrequency ablationRFA 50 only with drugs Change in average office-based measurements of systolic blood pressureSBP 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None