Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 2:27 AM
Study NCT ID:
NCT05743894
Status:
UNKNOWN
Last Update Posted:
2023-02-24
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RDN Fesibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006977', 'term': 'Hypertension, Renal'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the difference of RNS BP response before and after RDN', 'timeFrame': '24-hrs'}], 'secondaryOutcomes': [{'measure': 'the changes in 24-hour ABPM after RDN', 'timeFrame': '6 months'}, {'measure': 'the change in office BP measurement;', 'timeFrame': '6 months'}, {'measure': 'the change in the number and dosage of anti-hypertensives', 'timeFrame': '6 months'}, {'measure': 'the change in renal function as measured by estimated GFR', 'timeFrame': '6 months'}, {'measure': 'the change in renal function as measured by ratio urine albumin-creatinine', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal Sympathetic Denervation', 'Symplicity Spyral Radiofrequency Catheter', 'resistant hypertension'], 'conditions': ['Hypertension, Renal']}, 'referencesModule': {'references': [{'pmid': '22336259', 'type': 'RESULT', 'citation': 'Tam GM, Yan BP, Shetty SV, Lam YY. Transcatheter renal artery sympathetic denervation for resistant hypertension: an old paradigm revisited. Int J Cardiol. 2013 Apr 15;164(3):277-81. doi: 10.1016/j.ijcard.2012.01.048. Epub 2012 Feb 14.'}, {'pmid': '34261957', 'type': 'RESULT', 'citation': 'Schmieder RE, Mahfoud F, Mancia G, Azizi M, Bohm M, Dimitriadis K, Kario K, Kroon AA, D Lobo M, Ott C, Pathak A, Persu A, Scalise F, Schlaich M, Kreutz R, Tsioufis C; members of the ESH Working Group on Device-Based Treatment of Hypertension. European Society of Hypertension position paper on renal denervation 2021. J Hypertens. 2021 Sep 1;39(9):1733-1741. doi: 10.1097/HJH.0000000000002933.'}, {'pmid': '31221299', 'type': 'RESULT', 'citation': 'Weber MA, Mahfoud F, Schmieder RE, Kandzari DE, Tsioufis KP, Townsend RR, Kario K, Bohm M, Sharp ASP, Davies JE, Osborn JW, Fink GD, Euler DE, Cohen DL, Schlaich MP, Esler MD. Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence. JACC Cardiovasc Interv. 2019 Jun 24;12(12):1095-1105. doi: 10.1016/j.jcin.2019.02.050.'}, {'pmid': '21093036', 'type': 'RESULT', '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.'}, {'pmid': '24678939', 'type': 'RESULT', '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': '25400162', 'type': 'RESULT', 'citation': "Kandzari DE, Bhatt DL, Brar S, Devireddy CM, Esler M, Fahy M, Flack JM, Katzen BT, Lea J, Lee DP, Leon MB, Ma A, Massaro J, Mauri L, Oparil S, O'Neill WW, Patel MR, Rocha-Singh K, Sobotka PA, Svetkey L, Townsend RR, Bakris GL. Predictors of blood pressure response in the SYMPLICITY HTN-3 trial. Eur Heart J. 2015 Jan 21;36(4):219-27. doi: 10.1093/eurheartj/ehu441. Epub 2014 Nov 16."}, {'pmid': '28859944', 'type': 'RESULT', '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': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'Renal sympathetic denervation (RDN) was considered an effective alternative for patients whose blood pressure (BP) is not optimally controlled. The RDN works mainly by selectively disabling the nerves around the renal arteries and reducing blood pressure increase. However, despite the early success showed in the SYMPLICITY HTN-2 trial, the SYMPLICITY HTN-3 trial failed to demonstrate a significant BP reduction when compared to sham-control. incomplete disabling might result in inadequate denervation and were cited as some of the contributors to the nil result in the SYMPLICITY HTN-3 . The new generation of the Symplicity Spyral catheter aims to address some of these issues by altering the configuration of the catheter to allow better apposition to the renal arterial wall and increasing the numbers of electrodes to faciiitate more thorough ablations. However, the adequacy of sympathetic denervation with this new catheter can not be easily assessed at the time of the procedure as there is no simple physiological or biochemical feedbacks that can be monitored during the procedure. Blood pressure response by renal nerve simulation (RNS) during RDN procedure using the previous generation of the Symplicity Flex catheter have been reported to be potential parameter to assess the efficacy during the procedure and predict the BP response 6 months after RDN. The feasibility of RNS guided RDN procedure using the new generation of Symplicity Spyral catheter has not been reported. We therefore aim to explore the feasibility of RNS guided RDN with Symplicity Spyral Radiofrequency Catheter in patient with resistant hypertension.', 'detailedDescription': 'Renal sympathetic denervation (RDN) was considered an effective alternative for patients whose blood pressure (BP) is not optimally controlled. The RDN works mainly by selectively disabling the nerves around the renal arteries and reducing blood pressure increase. However, despite the early success showed in the SYMPLICITY HTN-2 trial, the SYMPLICITY HTN-3 trial failed to demonstrate a significant BP reduction when compared to sham-control. incomplete disabling might result in inadequate denervation and were cited as some of the contributors to the nil result in the SYMPLICITY HTN-3 . The new generation of the Symplicity Spyral catheter aims to address some of these issues by altering the configuration of the catheter to allow better apposition to the renal arterial wall and increasing the numbers of electrodes to faciiitate more thorough ablations. However, the adequacy of sympathetic denervation with this new catheter can not be easily assessed at the time of the procedure as there is no simple physiological or biochemical feedbacks that can be monitored during the procedure. Blood pressure response by renal nerve simulation (RNS) during RDN procedure using the previous generation of the Symplicity Flex catheter have been reported to be potential parameter to assess the efficacy during the procedure and predict the BP response 6 months after RDN. The feasibility of RNS guided RDN procedure using the new generation of Symplicity Spyral catheter has not been reported. We therefore aim to explore the feasibility of RNS guided RDN with Symplicity Spyral Radiofrequency Catheter in patient with resistant hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a feasibility study, small sample size serves as a proof of concept', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age \\> 18 years\n2. With resistant hypertension as defined by systolic BP over 140 mmHg on 24 hours ambulatory blood pressure measurement (ABPM)\n3. Already on a stable dose of at least 3 anti-hypertensive drugs of different classes for 3 months.\n4. subject is recruited for Transcatheter Renal Denervation\n\nExclusion Criteria:\n\n1. Individual has undergone prior renal denervation.\n2. Presence of renal artery stenosis \\>50%.\n3. Main renal artery diameter \\<3mm and larger than 8mm by visual assessment on angiography.\n4. Previous renal stenting.\n5. Subject with Estimated GFR \\<30ml/min/1.73m2 as calculated using the MDRD formula.\n6. Subject with renal transplant, single kidney, active nephritis or polycystic kidney disease.\n7. Subject with known pheochromocytoma, Cushing's Syndrome (hypercortisolism), primary hyperaldosteronism, coarctation of the aorta, untreated hyperthyroidism, untreated hypothyroidism, or primary hyperparathyroidism.\n8. Subject with unstable cardiac conditions such as myocardial infarction, unstable angina, malignant arrythmia, pulmonary embolism, significant valvular condition awaiting surgery or recent cerebrovascular accident within 3 months of recruitment.\n9. Subject who is pregnant or planning for pregnancy during the study duration.\n10. Subject who is enrolled in another device study for renal sympathetic denervation."}, 'identificationModule': {'nctId': 'NCT05743894', 'briefTitle': 'RDN Fesibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Renal Nerve Simulation Guided Renal Sympathetic Denervation With Siymplicity Spyral Radiofrequency Catheter for Resistant Hypertension: a Feasibility Study.', 'orgStudyIdInfo': {'id': '2022.391'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Symplicity Spyral RENAL DENERVATION (RDN) SYSTEMTM Livewire™ Reflexion™ Catheter', 'type': 'DEVICE', 'description': 'Renal sympathetic denervation (RDN) was considered an effective alternative for patients whose blood pressure (BP) is not optimally controlled. The RDN works mainly by selectively ablating the sympathetic fibres around the renal arteries and damping the sympathetic overdrive. Blood pressure response by renal nerve stimulation (RNS) during the RDN procedure using the previous generation of the Symplicity Flex catheter have been reported to be potential parameter to assess the intra-procedure efficacy and predict the BP response 6 months after RDN'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'GuangMing Tan', 'role': 'CONTACT', 'email': 'tg199@ha.org.hk', 'phone': '85255699658'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '0000', 'city': 'Hong Kong', 'state': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Daniel Xu', 'role': 'CONTACT', 'email': 'danielxu@cuhk.edu.hk', 'phone': '35051518', 'phoneExt': '1518'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Gormin Tan', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}