Impact of Renal SympAthetic DenerVation on Chronic HypErtension (SAVE)
Despite the development of many drug therapies designed to treat high blood pressure (hypertension), it remains a considerable and poorly managed health, social and economic burden. For various reasons, including the high health care costs of treatment, there are estimates that up to 65% of patients with high blood pressure have untreated and/or uncontrolled blood pressure (BP).
Aside from its effect on kidney function, chronic high blood pressure increases the risk for stroke, and heart disease. It is also thought to be involved in the formation of irregular heartbeats. This link between high blood pressure and heart health has been well described, as has their combined effect on the aging and the obesity-battling Western world.
A recently published study (Symplicity HTN-2 trial) established the benefit of a new treatment procedure, catheter-based renal sympathetic denervation (RSDN) for hypertension, as having enormous potential for the treatment of patients with high blood pressure. This multi-center trial will attempt to confirm and expand on these promising data. Patients who enroll in the trial will be followed for 4 years.
|Uncontrolled Hypertension||Device: Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Impact of Renal SympAthetic DenerVation on Chronic HypErtension|
- change in ambulatory blood pressure [ Time Frame: baseline and 6 months ]The change in blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.
- office BP [ Time Frame: up to 48 months ]Difference in office blood pressure measurements
- renal artery blood flow [ Time Frame: up to 48 months ]
- Renal artery dimensions [ Time Frame: up to 48 months ]
- BUN and creatinine [ Time Frame: up to 48 months ]
- Anti-hypertensive medications [ Time Frame: up to 48 months ]Difference in the total number of anti-hypertensive medications
|Study Start Date:||May 2012|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Renal denervation group
Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter
Device: Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter
Saline-Irrigated Radiofrequency Ablation Catheter will be placed in the renal arteries in a circumferential manner and energy will be delivered to create 4 burn lesions.
There are 2 devices that can be used---this is optional, based on physician preference:
Celcius Thermacool Catheter Biosense Webster, Inc Diamond Bar, California
Chilli II Cooled Ablation Catheter Boston Scientific Corporation San Jose, California
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01628198
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Vivek Reddy, MD||Icahn School of Medicine at Mount Sinai|