Impact of Renal SympAthetic DenerVation on Chronic HypErtension

NCT01628198 | Terminated Results DMC

• 1 other identifier: GCO 12-0740
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncontrolled Hypertension

Keywords

Hypertension; renal denervation; renal ablation; uncontrolled high blood pressure

Outcome Measures

Primary Outcomes (2)

• Mean Change in Ambulatory Systolic Blood Pressure

  The change in systolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.

  baseline and 6 months

• Change in Ambulatory Diastolic Blood Pressure

  The change in diastolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.

  baseline and 6 months

Secondary Outcomes (8)

• Office Systolic BP

  baseline, 6 month, 12 months

• Office Diastolic BP

  baseline, 6 month, 12 months

• Renal Aortic Ratio

  Baseline and 12 months

• Resistive Index

  Baseline and 12 months

• Renal Artery Dimensions

  baseline and 12 months

Study Arms (1)

Renal denervation group

EXPERIMENTAL

Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter

Device: Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter

Interventions

Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter DEVICE

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

Also known as: Renal Ablation, Renal denervation

Renal denervation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivek Reddy: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (28)

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  PMID: 19332353 BACKGROUND

• Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.

  PMID: 21093036 BACKGROUND

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Vivek Y Reddy
• Organization: Icahn School of Medicine at Mount Sinai

vivek.reddy@mountsinai.org

212-241-7114

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Cardiac Arrhythmia Service, Professor Of Medicine

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 26, 2012
• Study Start: October 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 19, 2018
• Results First Posted: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)