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Trial record 1 of 1 for:    NCT01628172
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Renal Sympathetic Denervation for the Management of Chronic Hypertension (RELIEF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628172
First Posted: June 26, 2012
Last Update Posted: June 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai
  Purpose

Despite the development of numerous drug therapies designed to treat hypertension, it remains a considerable and poorly managed health, social and economic burden. For various reasons, including the significant health care costs of treatment, there are estimates that up to 65% of hypertensive patients have untreated and/or uncontrolled blood pressure (BP).

Aside from its impact on renal function, chronic hypertension significantly increases the risk for stroke, coronary artery disease, heart failure, and vascular disease. It is believed to be involved in the progression of cardiac arrhythmias. This link between hypertension and cardiovascular health has been well described; as has their combined effect on the aging and obesity-battling Western world.

The recently published results of the Symplicity HTN-2 trial (Renal sympathetic denervation in patients with treatment resistant hypertension) establishing the therapeutic benefit of catheter-based renal sympathetic denervation for hypertension, have enormous potential for the management of a large and challenging patient population. The proposed, multicenter trial will attempt to confirm and expand on this promising data by conducting a double-blinded, placebo-controlled trial.

Patients may qualify to participate in this research study if their doctor has determined that they have drug-resistant, chronic hypertension.

Overall participation in this research study should be about 13 months which includes about 1 month to start the study procedure and 12 months of follow-up after the study procedure.


Condition Intervention
Uncontrolled Hypertension Device: Biosense Webster Celcius Thermacool catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Renal Sympathetic Denervation for the Management of Chronic Hypertension

Further study details as provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Change in 24-hour ambulatory BP [ Time Frame: baseline and at 6 months ]
    Differences in 24-hour ambulatory blood pressure measurements recorded at baseline and at 6 months for each patient.


Secondary Outcome Measures:
  • change in office BP [ Time Frame: baseline, 6 months, and 12 months ]
    Difference in office blood pressure measurements at 6 months and at 12 months as compared to baseline.

  • change in ambulatory BP [ Time Frame: baseline and at 12 months ]
    Difference in 24 hour ambulatory blood pressure measurements at 12 months compared to baseline

  • Renal artery dimensions [ Time Frame: baseline and at 6 months ]
    Change in renal artery dimensions at 6 months.

  • Creatinine [ Time Frame: baseline and at 6 months ]
    Differences in creatinine measurements recorded at baseline and at 6 months for each patient.


Enrollment: 96
Study Start Date: January 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biosense Webster Celcius Thermacool catheter
These subjects will undergo catheter-based sympathetic renal denervation. Ablation arm
Device: Biosense Webster Celcius Thermacool catheter
catheter-based sympathetic renal denervation
Other Names:
  • sympathetic renal denervation
  • Ablation arm
No Intervention: renal angiogram only
Control Group: Control arm will not receive intervention but will be followed for 1 year.

Detailed Description:

Patients who qualify for the study and provide consent will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney. The study doctor will assess whether the renal arteries are suitable to receive catheter-based renal denervation.

Both groups will receive sedation or anesthesia prior to the beginning of the procedure.

The first group will undergo catheter-based sympathetic renal denervation. Renal Sympathetic Denervation is a procedure that uses a catheter probe inserted into the renal (kidney) artery that deactivates the nerves that are linked to high blood pressure.

The second group will only receive renal angiography without the delivery of ablative energy.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  • Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring)
  • Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic)
  • 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:

  • Secondary cause of hypertension
  • White coat hypertension
  • Estimated GFR < 45
  • Type 1 Diabetes
  • Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
  • Life expectancy <1 year for any medical condition
  Contacts and Locations
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): NCT01628172


Locations
Czech Republic
Fakultní nemocnice u sv. Anny v Brně
Brno, Czech Republic, 53, 656 91
Na Homolce Hospital
Prague, Czech Republic, 15030
Sponsors and Collaborators
Vivek Reddy
Biosense Webster, Inc.
Investigators
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
  More Information

Publications:
Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. Erratum in: Circulation. 2011 Oct 18;124(16):e424. Circulation. 2010 Jul 6;122(1):e11. Circulation. 2009 Jan 27;119(3):e182.

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01628172     History of Changes
Other Study ID Numbers: GCO 11-0965
First Submitted: June 12, 2012
First Posted: June 26, 2012
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
renal sympathetic denervation
renal catheter ablation
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases