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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
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Brief Summary:

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

or

Chilli II Cooled Ablation Catheter Boston Scientific Corporation San Jose, California

Other Names:
  • Renal Ablation
  • Renal denervation



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Office Systolic BP [ Time Frame: baseline, 6 month, 12 months ]
    Different time points office systolic blood pressure measurements

  2. Office Diastolic BP [ Time Frame: baseline, 6 month, 12 months ]
    Different time points office diastolic blood pressure measurements

  3. 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.

  4. 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

  5. Renal Artery Dimensions [ Time Frame: baseline and 12 months ]
    Dimensions of renal artery, right and left

  6. 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.

  7. 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.

  8. Anti-hypertensive Medications [ Time Frame: Baseline, 6 months, 12 months ]
    The total number of anti-hypertensive medications at baseline, 6 months, and 12 months



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 and ≤ 85 years of age.
  • Refractory hypertension (per JNC-7, this is defined as BP ≥ 140/90 mmHg despite treatment with at least 3 anti-hypertensive drugs, at least one of which is a diuretic, or treatment by ≥ 4 anti-hypertensive drugs)
  • Stable anti-hypertensive drug regimen, where no modifications have occurred for at least 2 weeks.
  • Accessibility of renal vasculature.
  • Ability to understand the requirements of the study.
  • Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements.

Exclusion Criteria:

  • Subject has a known secondary cause of hypertension.
  • Subject has isolated White coat hypertension.
  • Subject has Type 1 Diabetes.
  • Subject has known significant renovascular abnormalities (e.g., significant renal artery stenosis, previous renal artery stenting or angioplasty that precludes the RSDN procedure because of no sites for ablation treatment, or the presence of an accessory renal artery in which the main renal artery is estimated to supply <75% of the kidney )
  • Significant renal artery stenosis is defined as > 50% diameter stenosis on renal angiography. Per the guidelines for noninvasive vascular laboratory testing: a report from the American Society of Echocardiography and the Society for Vascular Medicine and Biology, significant renal artery stenosis is defined by any one of the following criteria on renal duplex ultrasound; i) Renal artery to aorta peak systolic velocity ratio ≥ 3.5; ii) Peak Systolic Velocity > 200 cm/s with evidence of post-stenotic turbulence; iii) end diastolic velocity >150 cm/s ; iv) Resistive Index (RI) > 0.8; v) An occluded renal artery demonstrates no flow in the affected vessel.
  • Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
  • Subject has New York Heart Association (NYHA) Class III or IV congestive heart failure, due to either systolic or diastolic dysfunction.
  • Subject has an eGFR<45 ml/min/1.73m2 (calculated by using the modified diet in renal disease (MDRD) formula), and is not receiving dialysis.
  • Subject has orthostatic hypotension. (per the American Academy of Neurology/American Autonomic Society Conesus Statement, this is defined as a sustained reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of 10 mm Hg within 3 min of standing or head-up tilt to at least 60° on a tilt table)
  • Subject has a life expectancy < 1 year for any medical condition.
  • Subject is currently enrolled in another investigational drug or device trial that would interfere with this study.

Information from the National Library of Medicine

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


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Vivek Reddy
Investigators
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai

Publications:

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor Of Medicine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01628198     History of Changes
Other Study ID Numbers: GCO 12-0740
First Posted: June 26, 2012    Key Record Dates
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
Hypertension
renal denervation
renal ablation
uncontrolled high blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases