Back to resultsRadiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control (RAFALE)
Primary Purpose
Autosomal Dominant Polycystic Kidney Disease, Hypertension
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
renal sympathetic denervation
antihypertensive drugs
Sponsored by
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease focused on measuring hypertension, radiofrequency ablation, autosomal dominant polycystic kidney disease
Eligibility Criteria
Inclusion Criteria:
- Patients with ADPKD.
- Having hypertension, defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, and currently using 2 antihypertensive drugs and receiving a stable antihypertensive treatment regimen without change in dose or medication in the previous 30 days.
- Male and female patients 20 years to 60 years of age.
- Glomerular Filtration Rate (GFR) ≥30 ml/min/1.73 m2, estimated from serum creatinine using the Chronic Kidney Disease Epidemiology collaboration(CKD-EPI) equation.
- Have followed-up kidney and cyst volume at least 6 months in Shanghai Changzheng Hospital.
- Signed Informed Consent after being informed.
Exclusion Criteria:
- Documented renal vascular disease.
- Congenital absence of a kidney.
- Systemic illness with renal involvement.
- Spot urine albumin-to-creatinine ratio of >0.5 g/g and/or findings suggestive of kidney disease other than ADPKD.
- Exclusions specific to MRI acquisition and measurement: cardiac pacemaker, presence of MRI incompatible metallic clips or other material, excessive body weight, untreatable claustrophobia.
- Contraindications to the catheter-based renal denervation procedure by RFA, including allergy to radioiodinated contrast agents. Anatomical abnormalities of the renal arteries which preclude RFA: presence in either kidneys of multiple main renal arteries, main renal artery stenosis >50%, or main renal arteries of <4 mm in diameter or <20 mm in length.
- Contraindications on ethical grounds.
- Women who are pregnant or breast feeding.
- Intention to become pregnant during the course of the study.
- Lack of safe contraception: Female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential).
- Other clinically significant concomitant disease states (hepatic dysfunction, cardiovascular disease, metastatic cancer).
- Known or suspected non-compliance, drug or alcohol abuse.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Sites / Locations
- Department of Nephrology, Shanghai Changzheng HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
renal sympathetic denervation
antihypertensive drugs
Arm Description
One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation and using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).
Blood pressure control in ADPKD patients with hypertension only using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB)
Outcomes
Primary Outcome Measures
office-based measurements of systolic blood pressure
Between-group change in average office-based measurements of systolic blood pressure from baseline to 12 months after randomization and One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation.
Secondary Outcome Measures
24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)
Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) from baseline to 12 month.
Incidence of office systolic blood pressure reduction
Incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg from baseline to 12 month.
office diastolic blood pressure
Change in office diastolic blood pressure from baseline to 12 months.
number and dosage of blood pressure tablets
Change in number and dosage of blood pressure tablets from baseline to 12 months.
estimated Glomerular Filtration Rate(eGFR)
Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.
albuminuria
Change in albuminuria from baseline to 12 months.
total kidney volume (TKV)
Change in total kidney volume (TKV) from baseline to 12 months
pain
Change in pain related to cystic kidneys from baseline to 12 months.
procedure-related complications at femoral puncture site
Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).
Renal artery lesion
Renal artery lesion (perforation or dissection).
New renal artery stenosis
New renal artery stenosis >70%, determined by MRI within 12 months of randomization.
Embolic events
Embolic events.
hypotension
Episodes of hypotension.
hypertension.
Episodes of hypertension.
acute kidney injury
Acute deterioration of renal function
total cyst volume (TCV)
Change in total cyst volume (TCV) from baseline to 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01932450
Brief Title
Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control
Acronym
RAFALE
Official Title
A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mei changlin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized, open-label single-center study investigates the efficacy and safety of bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on blood pressure and disease progression control in autosomal dominant polycystic kidney disease(ADPKD). The total number of study subjects will be 100. All of them have diagnosed with ADPKD and hypertension. Patients will be randomized 1:1 (50 with radiofrequency ablation(RFA), 50 only with drugs). Change in average office-based measurements of systolic blood pressure(SBP), average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) , incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg , office diastolic blood pressure (DBP), number and dosage of blood pressure tablets, total kidney volume (TKV), total cyst volume (TCV), pain related to cystic kidneys and renal function, will be assessed at 12 months of follow-up. The safety variables will be assessed at every visit of follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease, Hypertension
Keywords
hypertension, radiofrequency ablation, autosomal dominant polycystic kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
renal sympathetic denervation
Arm Type
Experimental
Arm Description
One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation and using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).
Arm Title
antihypertensive drugs
Arm Type
Active Comparator
Arm Description
Blood pressure control in ADPKD patients with hypertension only using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB)
Intervention Type
Procedure
Intervention Name(s)
renal sympathetic denervation
Other Intervention Name(s)
Percutaneous radiofrequency ablation of renal nerves, Transcatheter renal denervation, renal denervation, renal ablation
Intervention Description
One-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation.
Intervention Type
Drug
Intervention Name(s)
antihypertensive drugs
Intervention Description
antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.
Primary Outcome Measure Information:
Title
office-based measurements of systolic blood pressure
Description
Between-group change in average office-based measurements of systolic blood pressure from baseline to 12 months after randomization and One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation.
Time Frame
baseline and 12 months (day 360±14)
Secondary Outcome Measure Information:
Title
24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)
Description
Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) from baseline to 12 month.
Time Frame
baseline and 12 months (day 360±14)
Title
Incidence of office systolic blood pressure reduction
Description
Incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg from baseline to 12 month.
Time Frame
baseline and 12 months (day 360±14)
Title
office diastolic blood pressure
Description
Change in office diastolic blood pressure from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
number and dosage of blood pressure tablets
Description
Change in number and dosage of blood pressure tablets from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
estimated Glomerular Filtration Rate(eGFR)
Description
Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
albuminuria
Description
Change in albuminuria from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
total kidney volume (TKV)
Description
Change in total kidney volume (TKV) from baseline to 12 months
Time Frame
baseline and 12 months (day 360±14)
Title
pain
Description
Change in pain related to cystic kidneys from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
procedure-related complications at femoral puncture site
Description
Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).
Time Frame
up to 1 year (after radiofrequency ablation)
Title
Renal artery lesion
Description
Renal artery lesion (perforation or dissection).
Time Frame
up to 1 year (after radiofrequency ablation)
Title
New renal artery stenosis
Description
New renal artery stenosis >70%, determined by MRI within 12 months of randomization.
Time Frame
up to 1 year (after radiofrequency ablation)
Title
Embolic events
Description
Embolic events.
Time Frame
up to 1 year (after radiofrequency ablation)
Title
hypotension
Description
Episodes of hypotension.
Time Frame
up to 1 year (after radiofrequency ablation)
Title
hypertension.
Description
Episodes of hypertension.
Time Frame
up to 1 year (after radiofrequency ablation)
Title
acute kidney injury
Description
Acute deterioration of renal function
Time Frame
up to 1 year (after radiofrequency ablation)
Title
total cyst volume (TCV)
Description
Change in total cyst volume (TCV) from baseline to 12 months
Time Frame
baseline and 12 months (day 360±14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with ADPKD.
Having hypertension, defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, and currently using 2 antihypertensive drugs and receiving a stable antihypertensive treatment regimen without change in dose or medication in the previous 30 days.
Male and female patients 20 years to 60 years of age.
Glomerular Filtration Rate (GFR) ≥30 ml/min/1.73 m2, estimated from serum creatinine using the Chronic Kidney Disease Epidemiology collaboration(CKD-EPI) equation.
Have followed-up kidney and cyst volume at least 6 months in Shanghai Changzheng Hospital.
Signed Informed Consent after being informed.
Exclusion Criteria:
Documented renal vascular disease.
Congenital absence of a kidney.
Systemic illness with renal involvement.
Spot urine albumin-to-creatinine ratio of >0.5 g/g and/or findings suggestive of kidney disease other than ADPKD.
Exclusions specific to MRI acquisition and measurement: cardiac pacemaker, presence of MRI incompatible metallic clips or other material, excessive body weight, untreatable claustrophobia.
Contraindications to the catheter-based renal denervation procedure by RFA, including allergy to radioiodinated contrast agents. Anatomical abnormalities of the renal arteries which preclude RFA: presence in either kidneys of multiple main renal arteries, main renal artery stenosis >50%, or main renal arteries of <4 mm in diameter or <20 mm in length.
Contraindications on ethical grounds.
Women who are pregnant or breast feeding.
Intention to become pregnant during the course of the study.
Lack of safe contraception: Female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential).
Other clinically significant concomitant disease states (hepatic dysfunction, cardiovascular disease, metastatic cancer).
Known or suspected non-compliance, drug or alcohol abuse.
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject.
Participation in another study with investigational drug within the 30 days preceding and during the present study.
Previous enrolment into the current study.
Enrolment of the investigator, his/her family members, employees and other dependent persons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changlin Mei, MD
Phone
+86 21 81885391
Email
chlmei1954@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yiyi Ma, Master
Phone
+8613661679863
Email
dukemm@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
Organizational Affiliation
Nephrology Department of Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
Phone
+862181885391
Email
chlmei1954@126.com
First Name & Middle Initial & Last Name & Degree
Yiyi Ma, Master
Phone
+8613661679863
Email
dukemm@126.com
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
First Name & Middle Initial & Last Name & Degree
Shengqiang Yu, PHD
First Name & Middle Initial & Last Name & Degree
Lin Li, PHD
First Name & Middle Initial & Last Name & Degree
Xueqi Wang, PHD
First Name & Middle Initial & Last Name & Degree
Chenggang Xu, PHD
First Name & Middle Initial & Last Name & Degree
Zhiguo Mao, PHD
First Name & Middle Initial & Last Name & Degree
Bing Dai, PHD
First Name & Middle Initial & Last Name & Degree
Yiyi Ma, Master
First Name & Middle Initial & Last Name & Degree
Dongping Chen, Master
12. IPD Sharing Statement
Citations:
PubMed Identifier
17434405
Citation
Torres VE, Harris PC, Pirson Y. Autosomal dominant polycystic kidney disease. Lancet. 2007 Apr 14;369(9569):1287-1301. doi: 10.1016/S0140-6736(07)60601-1.
Results Reference
background
PubMed Identifier
18947299
Citation
Harris PC, Torres VE. Polycystic kidney disease. Annu Rev Med. 2009;60:321-37. doi: 10.1146/annurev.med.60.101707.125712.
Results Reference
background
PubMed Identifier
18832246
Citation
Grantham JJ. Clinical practice. Autosomal dominant polycystic kidney disease. N Engl J Med. 2008 Oct 2;359(14):1477-85. doi: 10.1056/NEJMcp0804458. No abstract available.
Results Reference
background
PubMed Identifier
18075279
Citation
Chang MY, Ong AC. Autosomal dominant polycystic kidney disease: recent advances in pathogenesis and treatment. Nephron Physiol. 2008;108(1):p1-7. doi: 10.1159/000112495. Epub 2007 Dec 13.
Results Reference
background
PubMed Identifier
12187316
Citation
Neumann J, Ligtenberg G, Klein IH, Blankestijn PJ. Pathogenesis and treatment of hypertension in polycystic kidney disease. Curr Opin Nephrol Hypertens. 2002 Sep;11(5):517-21. doi: 10.1097/00041552-200209000-00007.
Results Reference
background
PubMed Identifier
9259356
Citation
Chapman AB, Johnson AM, Rainguet S, Hossack K, Gabow P, Schrier RW. Left ventricular hypertrophy in autosomal dominant polycystic kidney disease. J Am Soc Nephrol. 1997 Aug;8(8):1292-7. doi: 10.1681/ASN.V881292.
Results Reference
background
PubMed Identifier
11134267
Citation
Ecder T, Schrier RW. Hypertension in autosomal-dominant polycystic kidney disease: early occurrence and unique aspects. J Am Soc Nephrol. 2001 Jan;12(1):194-200. doi: 10.1681/ASN.V121194. No abstract available.
Results Reference
background
PubMed Identifier
20219618
Citation
Chapman AB, Stepniakowski K, Rahbari-Oskoui F. Hypertension in autosomal dominant polycystic kidney disease. Adv Chronic Kidney Dis. 2010 Mar;17(2):153-63. doi: 10.1053/j.ackd.2010.01.001.
Results Reference
background
PubMed Identifier
9730562
Citation
Cerasola G, Vecchi M, Mule G, Cottone S, Mangano MT, Andronico G, Contorno A, Parrino I, Renda F, Pavone G. Sympathetic activity and blood pressure pattern in autosomal dominant polycystic kidney disease hypertensives. Am J Nephrol. 1998;18(5):391-8. doi: 10.1159/000013382.
Results Reference
background
PubMed Identifier
11675419
Citation
Klein IHHT, Ligtenberg G, Oey PL, Koomans HA, Blankestijn PJ. Sympathetic activity is increased in polycystic kidney disease and is associated with hypertension. J Am Soc Nephrol. 2001 Nov;12(11):2427-2433. doi: 10.1681/ASN.V12112427.
Results Reference
background
PubMed Identifier
21601126
Citation
Schrier RW. Hypertension and autosomal dominant polycystic kidney disease. Am J Kidney Dis. 2011 Jun;57(6):811-3. doi: 10.1053/j.ajkd.2011.02.379. No abstract available.
Results Reference
background
PubMed Identifier
20089507
Citation
Chapman AB, Torres VE, Perrone RD, Steinman TI, Bae KT, Miller JP, Miskulin DC, Rahbari Oskoui F, Masoumi A, Hogan MC, Winklhofer FT, Braun W, Thompson PA, Meyers CM, Kelleher C, Schrier RW. The HALT polycystic kidney disease trials: design and implementation. Clin J Am Soc Nephrol. 2010 Jan;5(1):102-9. doi: 10.2215/CJN.04310709.
Results Reference
background
PubMed Identifier
22205355
Citation
Torres VE, Chapman AB, Perrone RD, Bae KT, Abebe KZ, Bost JE, Miskulin DC, Steinman TI, Braun WE, Winklhofer FT, Hogan MC, Oskoui FR, Kelleher C, Masoumi A, Glockner J, Halin NJ, Martin DR, Remer E, Patel N, Pedrosa I, Wetzel LH, Thompson PA, Miller JP, Meyers CM, Schrier RW; HALT PKD Study Group. Analysis of baseline parameters in the HALT polycystic kidney disease trials. Kidney Int. 2012 Mar;81(6):577-85. doi: 10.1038/ki.2011.411. Epub 2011 Dec 28.
Results Reference
background
PubMed Identifier
18480417
Citation
Gattone VH 2nd, Siqueira TM Jr, Powell CR, Trambaugh CM, Lingeman JE, Shalhav AL. Contribution of renal innervation to hypertension in rat autosomal dominant polycystic kidney disease. Exp Biol Med (Maywood). 2008 Aug;233(8):952-7. doi: 10.3181/0802-RM-54. Epub 2008 May 14.
Results Reference
background
PubMed Identifier
14712440
Citation
Chapuis O, Sockeel P, Pallas G, Pons F, Jancovici R. Thoracoscopic renal denervation for intractable autosomal dominant polycystic kidney disease-related pain. Am J Kidney Dis. 2004 Jan;43(1):161-3. doi: 10.1053/j.ajkd.2003.07.026.
Results Reference
background
PubMed Identifier
11209012
Citation
Valente JF, Dreyer DR, Breda MA, Bennett WM. Laparoscopic renal denervation for intractable ADPKD-related pain. Nephrol Dial Transplant. 2001 Jan;16(1):160. doi: 10.1093/ndt/16.1.160. No abstract available.
Results Reference
background
PubMed Identifier
20439087
Citation
Hogan MC, Norby SM. Evaluation and management of pain in autosomal dominant polycystic kidney disease. Adv Chronic Kidney Dis. 2010 May;17(3):e1-e16. doi: 10.1053/j.ackd.2010.01.005.
Results Reference
background
PubMed Identifier
13024041
Citation
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.
Results Reference
background
PubMed Identifier
13061307
Citation
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.
Results Reference
background
PubMed Identifier
13821037
Citation
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.
Results Reference
background
PubMed Identifier
19710497
Citation
Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med. 2009 Aug 27;361(9):932-4. doi: 10.1056/NEJMc0904179. No abstract available.
Results Reference
background
PubMed Identifier
22347190
Citation
Schlaich MP, Hering D, Sobotka P, Krum H, Lambert GW, Lambert E, Esler MD. Effects of renal denervation on sympathetic activation, blood pressure, and glucose metabolism in patients with resistant hypertension. Front Physiol. 2012 Feb 2;3:10. doi: 10.3389/fphys.2012.00010. eCollection 2012.
Results Reference
background
PubMed Identifier
19332353
Citation
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.
Results Reference
background
PubMed Identifier
21403086
Citation
Symplicity HTN-1 Investigators. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011 May;57(5):911-7. doi: 10.1161/HYPERTENSIONAHA.110.163014. Epub 2011 Mar 14.
Results Reference
background
PubMed Identifier
21093036
Citation
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.
Results Reference
background
PubMed Identifier
22573363
Citation
Kandzari DE, Bhatt DL, Sobotka PA, O'Neill WW, Esler M, Flack JM, Katzen BT, Leon MB, Massaro JM, Negoita M, Oparil S, Rocha-Singh K, Straley C, Townsend RR, Bakris G. Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 Trial. Clin Cardiol. 2012 Sep;35(9):528-35. doi: 10.1002/clc.22008. Epub 2012 May 9.
Results Reference
background
PubMed Identifier
22595301
Citation
Hering D, Mahfoud F, Walton AS, Krum H, Lambert GW, Lambert EA, Sobotka PA, Bohm M, Cremers B, Esler MD, Schlaich MP. Renal denervation in moderate to severe CKD. J Am Soc Nephrol. 2012 Jul;23(7):1250-7. doi: 10.1681/ASN.2011111062. Epub 2012 May 17.
Results Reference
background
PubMed Identifier
18370613
Citation
Casale P, Meyers K, Kaplan B. Follow-up for laparoscopic renal denervation and nephropexy for autosomal dominant polycystic kidney disease-related pain in pediatrics. J Endourol. 2008 May;22(5):991-3. doi: 10.1089/end.2007.0359.
Results Reference
background
PubMed Identifier
20509010
Citation
Schlaich MP, Krum H, Esler MD. New therapeutic approaches to resistant hypertension. Curr Hypertens Rep. 2010 Aug;12(4):296-302. doi: 10.1007/s11906-010-0119-1.
Results Reference
background
PubMed Identifier
20581391
Citation
Serra AL, Poster D, Kistler AD, Krauer F, Raina S, Young J, Rentsch KM, Spanaus KS, Senn O, Kristanto P, Scheffel H, Weishaupt D, Wuthrich RP. Sirolimus and kidney growth in autosomal dominant polycystic kidney disease. N Engl J Med. 2010 Aug 26;363(9):820-9. doi: 10.1056/NEJMoa0907419. Epub 2010 Jun 26.
Results Reference
background
PubMed Identifier
8598068
Citation
Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
Results Reference
background
PubMed Identifier
9883744
Citation
Celermajer DS. Testing endothelial function using ultrasound. J Cardiovasc Pharmacol. 1998;32 Suppl 3:S29-32.
Results Reference
background
PubMed Identifier
15643116
Citation
Deanfield J, Donald A, Ferri C, Giannattasio C, Halcox J, Halligan S, Lerman A, Mancia G, Oliver JJ, Pessina AC, Rizzoni D, Rossi GP, Salvetti A, Schiffrin EL, Taddei S, Webb DJ; Working Group on Endothelin and Endothelial Factors of the European Society of Hypertension. Endothelial function and dysfunction. Part I: Methodological issues for assessment in the different vascular beds: a statement by the Working Group on Endothelin and Endothelial Factors of the European Society of Hypertension. J Hypertens. 2005 Jan;23(1):7-17. doi: 10.1097/00004872-200501000-00004.
Results Reference
background
PubMed Identifier
17964069
Citation
Gemignani V, Bianchini E, Faita F, Giannarelli C, Plantinga Y, Ghiadoni L, Demi M. Ultrasound measurement of the brachial artery flow-mediated dilation without ECG gating. Ultrasound Med Biol. 2008 Mar;34(3):385-91. doi: 10.1016/j.ultrasmedbio.2007.08.006. Epub 2007 Oct 26.
Results Reference
background
PubMed Identifier
20956208
Citation
Sudano I, Flammer AJ, Periat D, Enseleit F, Hermann M, Wolfrum M, Hirt A, Kaiser P, Hurlimann D, Neidhart M, Gay S, Holzmeister J, Nussberger J, Mocharla P, Landmesser U, Haile SR, Corti R, Vanhoutte PM, Luscher TF, Noll G, Ruschitzka F. Acetaminophen increases blood pressure in patients with coronary artery disease. Circulation. 2010 Nov 2;122(18):1789-96. doi: 10.1161/CIRCULATIONAHA.110.956490. Epub 2010 Oct 18.
Results Reference
background
PubMed Identifier
16476843
Citation
Williams B, Lacy PS, Thom SM, Cruickshank K, Stanton A, Collier D, Hughes AD, Thurston H, O'Rourke M; CAFE Investigators; Anglo-Scandinavian Cardiac Outcomes Trial Investigators; CAFE Steering Committee and Writing Committee. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation. 2006 Mar 7;113(9):1213-25. doi: 10.1161/CIRCULATIONAHA.105.595496. Epub 2006 Feb 13.
Results Reference
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PubMed Identifier
12407781
Citation
Pannier B, Guerin A, London G, Asmar R, Safar M; REASON Study. [Combination of low-dose perindopril/indapamide versus atenolol in the hypertensive patient. Effects on systolic pressure and arterial hemodynamics. REASON Study]. Arch Mal Coeur Vaiss. 2002 Sep;95 Spec No 6:11-6. French.
Results Reference
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PubMed Identifier
17000623
Citation
Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.
Results Reference
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Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control
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