Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT05421767
Status:
RECRUITING
Last Update Posted:
2022-06-16
First Post:
2020-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Nerve Stimulation in Uncontrolled Hypertensive Patients Undergoing Renal Denervation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'RNS guided RDN'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RNS checked RDN'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arterial blood pressure response', 'timeFrame': 'during procedure', 'description': 'Main study parameter will be the arterial blood pressure response to RNS immediately after RDN.'}], 'secondaryOutcomes': [{'measure': 'blood pressure at 6 months', 'timeFrame': '6 months after the intervention', 'description': '24 hours Blood pressure at 6 months after the intervention'}, {'measure': 'blood pressure at 12 months', 'timeFrame': '12 months after the intervention', 'description': '24 hours Blood pressure at 12 months after the intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal nerve stimulation', 'renal nerve denervation', 'Sympathetic nerve activity'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '22025634', 'type': 'BACKGROUND', 'citation': 'Rodeheffer RJ. Hypertension and heart failure: the ALLHAT imperative. Circulation. 2011 Oct 25;124(17):1803-5. doi: 10.1161/CIRCULATIONAHA.111.059303. No abstract available.'}, {'pmid': '24678939', 'type': 'BACKGROUND', 'citation': "Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29."}, {'pmid': '28859944', 'type': 'BACKGROUND', 'citation': 'Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Bohm M; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170. doi: 10.1016/S0140-6736(17)32281-X. Epub 2017 Aug 28.'}, {'pmid': '29803589', 'type': 'BACKGROUND', 'citation': 'Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.'}, {'pmid': '29803590', 'type': 'BACKGROUND', 'citation': 'Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23.'}, {'pmid': '30608521', 'type': 'BACKGROUND', 'citation': 'Bohm M, Mahfoud F, Townsend RR, Kandzari DE, Pocock S, Ukena C, Weber MA, Hoshide S, Patel M, Tyson CC, Weil J, Agdirlioglu T, Fahy M, Kario K. Ambulatory heart rate reduction after catheter-based renal denervation in hypertensive patients not receiving anti-hypertensive medications: data from SPYRAL HTN-OFF MED, a randomized, sham-controlled, proof-of-concept trial. Eur Heart J. 2019 Mar 1;40(9):743-751. doi: 10.1093/eurheartj/ehy871.'}, {'pmid': '31327262', 'type': 'BACKGROUND', 'citation': 'Liu H, Chen W, Lai Y, Du H, Wang Z, Xu Y, Ling Z, Fan J, Xiao P, Zhang B, Wang J, Gyawali L, Zrenner B, Woo K, Yin Y. Selective Renal Denervation Guided by Renal Nerve Stimulation in Canine. Hypertension. 2019 Sep;74(3):536-545. doi: 10.1161/HYPERTENSIONAHA.119.12680. Epub 2019 Jul 22.'}, {'pmid': '25339295', 'type': 'BACKGROUND', 'citation': 'Gal P, de Jong MR, Smit JJ, Adiyaman A, Staessen JA, Elvan A. Blood pressure response to renal nerve stimulation in patients undergoing renal denervation: a feasibility study. J Hum Hypertens. 2015 May;29(5):292-5. doi: 10.1038/jhh.2014.91. Epub 2014 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'Study design: Investigator initiated, single center The study is aimed\n\n1\\) To investigate the blood pressure (BP) change to renal nerve stimulation(RNS), and subsequently perform a renal denervation(RDN) procedure\n\n1\\) to verify the cutoff value (RNS-induced systolic BP change \\<20 mmHg in post-RDN patients) could be a useful clinical endpoint in RDN therapy, and test the hypothesis that intense RDN could improve the efficacy of RDN.', 'detailedDescription': 'Hypertension has become a global public health concern and associated with considerable risk of cardiovascular, cerebrovascular and kidney diseases. Although pharmacological blood pressure (BP) control can reduce these risks, BP control rates remain suboptimal. Resistant hypertension affects 10% to 15% of patients with hypertension and adequate BP control is associated with better clinical outcome of resistant hypertension. Percutaneous renal denervation system (RDN) is designed to disrupt renal afferent and efferent sympathetic nerves to modulate central sympathetic outflow and renal physiology, achieving sustained BP reduction. Although the randomized, sham-controlled trial, SYMPLICITY HTN-3 in 2014, failed to prove the effectiveness of RDN in reducing BP compared to sham procedure, three carefully designed, randomized sham-controlled RDN trials (SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, and RADIANCE-HTN SOLO), all of which showed similar and clinically meaningful BP reductions without serious adverse events. RDN, therefore, has been approved and well utilized in clinical practice to treat resistant hypertension. However,15-30% of the patients are non-responders. The reason for this is unknown. Experimental data show that renal nerve stimulation (RNS) may serve as a functional endpoint to assess completeness of the RDN procedure. Our preliminary observation study showed low RNS-induced SBP change in post-RDN patients were associated with better BP lowering response.\n\nOur study objectives are\n\n1\\) to investigate the BP change to RNS, and subsequently perform a RDN procedure\n\n1\\) to verify the cutoff value (RNS-induced systolic BP change \\<20mmHg in post-RDN patients) could be a useful clinical endpoint in RDN therapy.\n\nHypotheses:\n\nWe hypothesize that an RNS-induced SBP increase of \\<20 mmHg in bilateral proximal main renal arteries immediately after RDN was associated with significant BP reductions 6 months following RDN. RNS-induced SBP changes could predict RDN response and even guide RDN strategies\n\nStudy design: Investigator initiated, single center, prospective study Patient population: 60 patients (20 - 80 years old) Patients with HTN.\n\n1\\) 24-hour ambulatory blood pressure monitoring (ABPM) was \\>130 or DBP \\>80 mmHg\n\nExclusion criteria:\n\n1. Unsuitable renal artery anatomy (main renal artery lumen diameter ≤3 mm or a total length \\<20 mm of the main arteries).\n2. Secondary hypertension, including hyperaldosteronism, pheochromocytoma, renal artery stenosis(\\>50% stenosis in one or both arteries)\n3. Pregnancy\n\nIntervention:\n\nRNS-guided RDN will be performed\n\n1. Group A (N=35): RNS-induced SBP increase of \\<20 mmHg in bilateral proximal main renal arteries immediately after RDN\n2. Group B(N=25): RNS-induced SBP increase of \\>20 mmHg in bilateral proximal main renal arteries immediately after RDN Then we will further divided Group B into Group C (N=8): observation group Group D(N=17): intensive intervention group (intensive -RDN again and the goal was post RNS-induced SBP change \\<20 mmHg)\n\nPrimary end-points:\n\nThe primary end points were the low RNS-induced systolic BP changes after RDN, was associated with the lower 24-hour SBP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with hypertension (HTN), including\n\n1. 24-hour ambulatory blood pressure \\>130/ 80 mmHg\n2. Age 20-80 years\n3. Glomerular filtration rate \\>45 mL/min\n\nExclusion Criteria:\n\n1. Unsuitable renal artery anatomy computed tomographic angiography (main renal artery lumen diameter ≤3 mm or a total length \\<20 mm of the main arteries).\n2. untreated secondary HTN, including hyperaldosteronism, pheochromocytoma, renal artery stenosis(\\>50% stenosis)'}, 'identificationModule': {'nctId': 'NCT05421767', 'acronym': 'RND', 'briefTitle': 'Renal Nerve Stimulation in Uncontrolled Hypertensive Patients Undergoing Renal Denervation', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'National Tawan University Hospital', 'orgStudyIdInfo': {'id': '201902040RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low RNS-induced SBP change group', 'description': '25 patients with the RNS-induced systolic BP change \\<20mmHg immediately after RDN', 'interventionNames': ['Procedure: nerve stimulation guided renal denervation procedure']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High RNS-induced SBP change group', 'description': '8 patients with the RNS-induced systolic BP change \\>20mmHg immediately after RDN', 'interventionNames': ['Procedure: nerve stimulation guided renal denervation procedure']}, {'type': 'EXPERIMENTAL', 'label': 'intensive RDN group', 'description': '17 patients with the initial RNS-induced systolic BP change \\>20mmHg immediately after RDN, received intensive RDN therapy and let the second RNS-induced systolic BP change \\< 20mmHg', 'interventionNames': ['Procedure: nerve stimulation guided renal denervation procedure']}], 'interventions': [{'name': 'nerve stimulation guided renal denervation procedure', 'type': 'PROCEDURE', 'otherNames': ['RNS-guided RDN'], 'description': 'RNS-in', 'armGroupLabels': ['High RNS-induced SBP change group', 'Low RNS-induced SBP change group', 'intensive RDN group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hui-Chun Huang, M.D', 'role': 'CONTACT', 'email': 'hchuangster@ntuh.gov.tw', 'phone': '886-23123456', 'phoneExt': '62152'}, {'name': 'Tzung-Dau Wang, PHD', 'role': 'CONTACT', 'email': 'tdwang@ntu.edu.tw', 'phone': '886-23123456', 'phoneExt': '62152'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}