Impact of Renal SympAthetic DenerVation on Chronic HypErtension (SAVE)
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|ClinicalTrials.gov Identifier: NCT01628198|
Recruitment Status : Terminated (recommendation by the study's DSMB due to insufficient data to determine efficacy.)
First Posted : June 26, 2012
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Uncontrolled Hypertension||Device: Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Renal SympAthetic DenerVation on Chronic HypErtension|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
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
- Mean Change in Ambulatory Systolic Blood Pressure [ Time Frame: baseline and 6 months ]The change in systolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.
- Change in Ambulatory Diastolic Blood Pressure [ Time Frame: baseline and 6 months ]The change in diastolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.
- Office Systolic BP [ Time Frame: baseline, 6 month, 12 months ]Different time points office systolic blood pressure measurements
- Office Diastolic BP [ Time Frame: baseline, 6 month, 12 months ]Different time points office diastolic blood pressure measurements
- Renal Aortic Ratio [ Time Frame: Baseline and 12 months ]Renal artery blood flow as measured by Renal Aortic Ratio (RAR) = Peak systolic Velocity renal artery / Peak Systolic Velocity Aorta. A >60% stenosis is reported when there is a >3.5:1 Renal to Aortic Ratio.
- Resistive Index [ Time Frame: Baseline and 12 months ]Renal artery blood flow as measured by Resistive Index. RI = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity. the normal value is ~ 0.60, with 0.70 being around the upper limits of normal
- Renal Artery Dimensions [ Time Frame: baseline and 12 months ]Dimensions of renal artery, right and left
- Blood Urea Nitrogen [ Time Frame: baseline, 6 months, 12 months ]A blood urea nitrogen (BUN) test measures the amount of nitrogen in blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out in the urine.
- Creatinine [ Time Frame: baseline, 6 months, 12 months ]Creatinine measures the level of the waste product in the body. The amount of creatinine in the blood depends partly on the amount of muscle tissue you have. Men generally have higher creatinine levels than women.Normal levels of creatinine in the blood are approximately 0.6 to 1.2 milligrams (mg) per deciliter (dL) in adult males and 0.5 to 1.1 milligrams per deciliter in adult females. High levels of creatinine indicates kidney impairment.
- Anti-hypertensive Medications [ Time Frame: Baseline, 6 months, 12 months ]The total number of anti-hypertensive medications at baseline, 6 months, and 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|