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| ID | Type | Description | Link |
|---|---|---|---|
| RDN-ESRD-CMC-01 | Other Grant/Funding Number | Daewoong, Daichi-Sankyo |
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| Name | Class |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | INDUSTRY |
| Daiichi Sankyo Korea Co., Ltd. | INDUSTRY |
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A. Hypertension is a major cardiovascular risk factor and numerous treatment strategies have been developed to treat hypertension properly and reduce cardiovascular risk.
B. However, there is a subgroup of hypertension which are resistant to treatment.
D. Sympathetic hyperactivity is observed in ESRD patients E. Catheter based renal sympathetic denervation is expected to improve resistant hypertension in ESRD patients
F. The aim the present study is to evaluate the effects and safety of catheter based renal sympathetic denervation on resistant hypertension in ESRD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal sympathetic denervation | Experimental | Renal sympathetic denervation procedure plus antihypertensive medication (doses and types of medication are maintained as previously prescribed) |
|
| Medical therapy | Sham Comparator | renal angiogram plus antihypertensive medications (doses and types of medication are maintained as previously prescribed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal sympathetic denervation | Procedure | In the experimental arm, Intervention is renal sympathetic denervation using Symplicity® system (Medtronic Ardian Inc, Mountain View, CA, USA) and antihypertensive medications previously prescribed
In the sham comparator, intervention is renal angiogram and continue antihypertensive medications previuosly decribed |
| Measure | Description | Time Frame |
|---|---|---|
| The change of office systolic blood pressure after renal denervation | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change of office diastolic blood pressure | 6 month | |
| change in ambulatory blood pressure monitroing(ABPM): mean systolic blood pressure(SBP)/diastolic blood pressure(DBP), mean heart rate(HR), BP variability | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
Known secondary hypertension patients
Patients who have renal artery which is not adequate for renal denervation
Patients who have history of myocardial infarction, unstable angina, syncope cerebrovascular insufficiency or extensive atherosclerotic disease with intravascular thrombosis, or unstable plaque
Type 1 Diabetes
Patients who have scheduled percutaneous coronary intervention (PCI) or operation within 6 months
Hemodynamically significant valvular heart disease in which blood pressure reduction may cause significant deterioration of patient's health.
Primary pulmonary hypertension
Patients who have the intracardiac defibrillator(ICD) or pacemaker which do not allow delivery of radiofrequency energy.
Patients who require continuous oxygen supply or mechanical ventilation for treatment of obstructive sleep apnea
Patients who have serious medical condition which can compromise the safety of the patients and the safety and integrity of the study.
Patients who have unresolved drug issue, alcoholism
Patients who lack ability to understand and follow the instruction the researcher
Patient who cannot follow up
Patients who are registered in other trial
Patients who are pregnant, nursing or planning to be pregnant
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kiyuk Chang, MD, PhD | Contact | +822-2258-1139 | kiyuk@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kiyuk Chang, MD, PhD | Seoul St. Mary's Hospital | Principal Investigator |
| Sung Ho Her, MD, PhD | Daejon St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejon St. Mary's Hospital | Recruiting | Daejeon | Chungchung Nam Do | 301-723 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23453868 | Background | Schlaich MP, Bart B, Hering D, Walton A, Marusic P, Mahfoud F, Bohm M, Lambert EA, Krum H, Sobotka PA, Schmieder RE, Ika-Sari C, Eikelis N, Straznicky N, Lambert GW, Esler MD. Feasibility of catheter-based renal nerve ablation and effects on sympathetic nerve activity and blood pressure in patients with end-stage renal disease. Int J Cardiol. 2013 Oct 3;168(3):2214-20. doi: 10.1016/j.ijcard.2013.01.218. Epub 2013 Feb 28. | |
| 23248063 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
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| Change in plasma norepinephrine | 6 months |
| Change in pulse wave velocity | 6 months |
| Chungnam National University | Recruiting | Daejeon | Chungchungnamdo | 301-721 | South Korea |
|
| Pohang St. Mary's Hospital | Recruiting | Pohang | Kyungsangnamdo | 790-825 | South Korea |
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| Seoul St. Mary's Hospital | Recruiting | Seoul | Seoul | 137-701 | South Korea |
|
| Background |
| Esler MD, Krum H, Schlaich M, Schmieder RE, Bohm M, Sobotka PA; Symplicity HTN-2 Investigators. Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012 Dec 18;126(25):2976-82. doi: 10.1161/CIRCULATIONAHA.112.130880. |
| 21403086 | Background | 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. |