Impact of Renal SympAthetic DenerVation on Chronic HypErtension (SAVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01628198
First received: June 12, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention
Uncontrolled Hypertension
Device: Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Renal SympAthetic DenerVation on Chronic HypErtension

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • change in ambulatory blood pressure [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The change in blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.


Secondary Outcome Measures:
  • office BP [ Time Frame: up to 48 months ] [ Designated as safety issue: No ]
    Difference in office blood pressure measurements

  • renal artery blood flow [ Time Frame: up to 48 months ] [ Designated as safety issue: No ]
  • Renal artery dimensions [ Time Frame: up to 48 months ] [ Designated as safety issue: No ]
  • BUN and creatinine [ Time Frame: up to 48 months ] [ Designated as safety issue: No ]
  • Anti-hypertensive medications [ Time Frame: up to 48 months ] [ Designated as safety issue: No ]
    Difference in the total number of anti-hypertensive medications


Estimated Enrollment: 500
Study Start Date: May 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628198

Contacts
Contact: Betsy Ellsworth, MSN 212-824-8902 betsy.ellsworth@mountsinai.org
Contact: Nicole Rothman, CRC 212-824-8909 Nicole.Rothman@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Betsy Ellsworth, MSN    212-824-8902    Betsy.Ellsworth@mountsinai.org   
Principal Investigator: Vivek Reddy, MD         
Sponsors and Collaborators
Vivek Reddy
Investigators
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor Of Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01628198     History of Changes
Other Study ID Numbers: GCO 12-0740
Study First Received: June 12, 2012
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Hypertension
renal denervation
renal ablation
uncontrolled high blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014