Renal Sympathetic Denervation for the Management of Chronic Hypertension
NCT ID: NCT01628172
Last Updated: 2016-06-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
96 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-01-31
Study Completion Date
2014-03-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Uncontrolled Hypertension
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Biosense Webster Celcius Thermacool catheter
These subjects will undergo catheter-based sympathetic renal denervation. Ablation arm
Group Type
EXPERIMENTAL
Biosense Webster Celcius Thermacool catheter
Intervention Type
DEVICE
catheter-based sympathetic renal denervation
renal angiogram only
Control Group: Control arm will not receive intervention but will be followed for 1 year.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Biosense Webster Celcius Thermacool catheter
catheter-based sympathetic renal denervation
Intervention Type
DEVICE
Other Intervention Names
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sympathetic renal denervation
Ablation arm
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Sponsor Role
collaborator
Vivek Reddy
OTHER
Sponsor Role
lead
Responsible Party
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Vivek Reddy
Director Cardiac Arrhythmia Service, Professor of Medicine
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Fakultní nemocnice u sv. Anny v Brně
Brno, , Czechia
Site Status
Na Homolce Hospital
Prague, , Czechia
Site Status
Countries
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Czechia
References
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Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.
Reference Type
BACKGROUND
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. No abstract available.
Reference Type
BACKGROUND
Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1.
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BACKGROUND
Sarafidis PA, Bakris GL. Resistant hypertension: an overview of evaluation and treatment. J Am Coll Cardiol. 2008 Nov 25;52(22):1749-57. doi: 10.1016/j.jacc.2008.08.036.
Reference Type
BACKGROUND
Cutler JA, Sorlie PD, Wolz M, Thom T, Fields LE, Roccella EJ. Trends in hypertension prevalence, awareness, treatment, and control rates in United States adults between 1988-1994 and 1999-2004. Hypertension. 2008 Nov;52(5):818-27. doi: 10.1161/HYPERTENSIONAHA.108.113357. Epub 2008 Oct 13.
Reference Type
BACKGROUND
Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.
Reference Type
BACKGROUND
DiBona GF. Sympathetic nervous system and the kidney in hypertension. Curr Opin Nephrol Hypertens. 2002 Mar;11(2):197-200. doi: 10.1097/00041552-200203000-00011.
Reference Type
BACKGROUND
DiBona GF, Kopp UC. Neural control of renal function. Physiol Rev. 1997 Jan;77(1):75-197. doi: 10.1152/physrev.1997.77.1.75.
Reference Type
BACKGROUND
Esler M, Jennings G, Korner P, Willett I, Dudley F, Hasking G, Anderson W, Lambert G. Assessment of human sympathetic nervous system activity from measurements of norepinephrine turnover. Hypertension. 1988 Jan;11(1):3-20. doi: 10.1161/01.hyp.11.1.3. No abstract available.
Reference Type
BACKGROUND
Schlaich MP, Lambert E, Kaye DM, Krozowski Z, Campbell DJ, Lambert G, Hastings J, Aggarwal A, Esler MD. Sympathetic augmentation in hypertension: role of nerve firing, norepinephrine reuptake, and Angiotensin neuromodulation. Hypertension. 2004 Feb;43(2):169-75. doi: 10.1161/01.HYP.0000103160.35395.9E. Epub 2003 Nov 10.
Reference Type
BACKGROUND
MORRISSEY DM, BROOKES VS, COOKE WT. Sympathectomy in the treatment of hypertension; review of 122 cases. Lancet. 1953 Feb 28;1(6757):403-8. doi: 10.1016/s0140-6736(53)91589-x. No abstract available.
Reference Type
BACKGROUND
SMITHWICK RH, THOMPSON JE. Splanchnicectomy for essential hypertension; results in 1,266 cases. J Am Med Assoc. 1953 Aug 15;152(16):1501-4. doi: 10.1001/jama.1953.03690160001001. No abstract available.
Reference Type
BACKGROUND
EVELYN KA, SINGH MM, CHAPMAN WP, PERERA GA, THALER H. Effect of thoracolumbar sympathectomy on the clinical course of primary (essential) hypertension. A ten-year study of 100 sympathectomized patients compared with individually matched, symptomatically treated control subjects. Am J Med. 1960 Feb;28:188-221. doi: 10.1016/0002-9343(60)90184-4. No abstract available.
Reference Type
BACKGROUND
Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
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BACKGROUND
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1.
Reference Type
BACKGROUND
Grassi G, Seravalle G, Quarti-Trevano F, Dell'Oro R, Bombelli M, Cuspidi C, Facchetti R, Bolla G, Mancia G. Adrenergic, metabolic, and reflex abnormalities in reverse and extreme dipper hypertensives. Hypertension. 2008 Nov;52(5):925-31. doi: 10.1161/HYPERTENSIONAHA.108.116368. Epub 2008 Sep 8.
Reference Type
BACKGROUND
DiBona GF. Renal innervation and denervation: lessons from renal transplantation reconsidered. Artif Organs. 1987 Dec;11(6):457-62. doi: 10.1111/j.1525-1594.1987.tb02710.x.
Reference Type
BACKGROUND
O'Brien E, Sheridan J, O'Malley K. Dippers and non-dippers. Lancet. 1988 Aug 13;2(8607):397. doi: 10.1016/s0140-6736(88)92867-x. No abstract available.
Reference Type
BACKGROUND
Hausberg M, Kosch M, Harmelink P, Barenbrock M, Hohage H, Kisters K, Dietl KH, Rahn KH. Sympathetic nerve activity in end-stage renal disease. Circulation. 2002 Oct 8;106(15):1974-9. doi: 10.1161/01.cir.0000034043.16664.96.
Reference Type
BACKGROUND
Schlaich MP, Socratous F, Hennebry S, Eikelis N, Lambert EA, Straznicky N, Esler MD, Lambert GW. Sympathetic activation in chronic renal failure. J Am Soc Nephrol. 2009 May;20(5):933-9. doi: 10.1681/ASN.2008040402. Epub 2008 Sep 17.
Reference Type
BACKGROUND
DiBona GF. Neural control of the kidney: past, present, and future. Hypertension. 2003 Mar;41(3 Pt 2):621-4. doi: 10.1161/01.HYP.0000047205.52509.8A. Epub 2002 Dec 16.
Reference Type
BACKGROUND
Fagius J. Sympathetic nerve activity in metabolic control--some basic concepts. Acta Physiol Scand. 2003 Mar;177(3):337-43. doi: 10.1046/j.1365-201X.2003.01086.x.
Reference Type
BACKGROUND
Joles JA, Koomans HA. Causes and consequences of increased sympathetic activity in renal disease. Hypertension. 2004 Apr;43(4):699-706. doi: 10.1161/01.HYP.0000121881.77212.b1. Epub 2004 Feb 23.
Reference Type
BACKGROUND
Luippold G, Beilharz M, Muhlbauer B. Chronic renal denervation prevents glomerular hyperfiltration in diabetic rats. Nephrol Dial Transplant. 2004 Feb;19(2):342-7. doi: 10.1093/ndt/gfg584.
Reference Type
BACKGROUND
Ye S, Zhong H, Yanamadala V, Campese VM. Renal injury caused by intrarenal injection of phenol increases afferent and efferent renal sympathetic nerve activity. Am J Hypertens. 2002 Aug;15(8):717-24. doi: 10.1016/s0895-7061(02)02959-x.
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BACKGROUND
Campese VM, Kogosov E, Koss M. Renal afferent denervation prevents the progression of renal disease in the renal ablation model of chronic renal failure in the rat. Am J Kidney Dis. 1995 Nov;26(5):861-5. doi: 10.1016/0272-6386(95)90456-5.
Reference Type
BACKGROUND
Other Identifiers
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GCO 11-0965
Identifier Type: -
Identifier Source: org_study_id
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