Clinical trial NCT05179343 - References

High Blood Pressure — SCRATCH-HTN Study: Evaluating Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Hypertensive Patients

Citation(s)

•   Abegaz TM, Shehab A, Gebreyohannes EA, Bhagavathula AS, Elnour AA
  Nonadherence to antihypertensive drugs: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Jan;96(4):e5641. doi: 10.1097/MD.0000000000005641.
•   Achelrod D, Wenzel U, Frey S
  Systematic review and meta-analysis of the prevalence of resistant hypertension in treated hypertensive populations. Am J Hypertens. 2015 Mar;28(3):355-61. doi: 10.1093/ajh/hpu151. Epub 2014 Aug 25.
•   Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Lobo MD, Sharp ASP, Bloch MJ, Basile J, Wang Y, Saxena M, Lurz P, Rader F, Sayer J, Fisher NDL, Fouassier D, Barman NC, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators
  Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019 May 28;139(22):2542-2553. doi: 10.1161/CIRCULATIONAHA.119.040451. Epub 2019 Mar 17.
•   Bang H, Ni L, Davis CE
  Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.
•   Bastien CH, Vallieres A, Morin CM
  Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
•   Bretherton B, Atkinson L, Murray A, Clancy J, Deuchars S, Deuchars J
  Effects of transcutaneous vagus nerve stimulation in individuals aged 55 years or above: potential benefits of daily stimulation. Aging (Albany NY). 2019 Jul 30;11(14):4836-4857. doi: 10.18632/aging.102074.
•   Carey RM, Calhoun DA, Bakris GL, Brook RD, Daugherty SL, Dennison-Himmelfarb CR, Egan BM, Flack JM, Gidding SS, Judd E, Lackland DT, Laffer CL, Newton-Cheh C, Smith SM, Taler SJ, Textor SC, Turan TN, White WB; American Heart Association Professional/Public Education and Publications Committee of the Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Genomic and Precision Medicine; Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Stroke Council
  Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association. Hypertension. 2018 Nov;72(5):e53-e90. doi: 10.1161/HYP.0000000000000084.
•   Clancy JA, Mary DA, Witte KK, Greenwood JP, Deuchars SA, Deuchars J
  Non-invasive vagus nerve stimulation in healthy humans reduces sympathetic nerve activity. Brain Stimul. 2014 Nov-Dec;7(6):871-7. doi: 10.1016/j.brs.2014.07.031. Epub 2014 Jul 16.
•   Dahal K, Khan M, Siddiqui N, Mina G, Katikaneni P, Modi K, Azrin M, Lee J
  Renal Denervation in the Management of Hypertension: A Meta-Analysis of Sham-Controlled Trials. Cardiovasc Revasc Med. 2020 Apr;21(4):532-537. doi: 10.1016/j.carrev.2019.07.012. Epub 2019 Jul 26.
•   Egan BM, Kjeldsen SE, Grassi G, Esler M, Mancia G
  The global burden of hypertension exceeds 1.4 billion people: should a systolic blood pressure target below 130 become the universal standard? J Hypertens. 2019 Jun;37(6):1148-1153. doi: 10.1097/HJH.0000000000002021.
•   England PH
  Health matters: preventing cardiovascular disease 2019.
•   England PH
  Hypertension prevalence estimates in England. 2017;2020.
•   England PH
  Tackling high blood pressure From evidence into action. 2014.
•   Ettehad D, Emdin CA, Kiran A, Anderson SG, Callender T, Emberson J, Chalmers J, Rodgers A, Rahimi K
  Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016 Mar 5;387(10022):957-967. doi: 10.1016/S0140-6736(15)01225-8. Epub 2015 Dec 24.
•   Foundation BH
  BHF Coronavirus and Heart & Circulatory Disease Statistics. 2020.
•   Gupta A, Prince M, Bob-Manuel T, Jenkins JS
  Renal denervation: Alternative treatment options for hypertension? Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):51-57. doi: 10.1016/j.pcad.2019.12.007. Epub 2019 Dec 27.
•   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.
•   Markle W, M
  Fisher, and R. Smego. Understanding Global Health. Economics and Global Health. 2007.
•   Mueller ST, Piper BJ
  The Psychology Experiment Building Language (PEBL) and PEBL Test Battery. J Neurosci Methods. 2014 Jan 30;222:250-9. doi: 10.1016/j.jneumeth.2013.10.024. Epub 2013 Nov 20.
•   Rahimi K
  Blood pressure reduction - lower really is better. European Society of Cardiology. 2020.
•   Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A
  Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.
•   van Bilsen M, Patel HC, Bauersachs J, Bohm M, Borggrefe M, Brutsaert D, Coats AJS, de Boer RA, de Keulenaer GW, Filippatos GS, Floras J, Grassi G, Jankowska EA, Kornet L, Lunde IG, Maack C, Mahfoud F, Pollesello P, Ponikowski P, Ruschitzka F, Sabbah HN, Schultz HD, Seferovic P, Slart RHJA, Taggart P, Tocchetti CG, Van Laake LW, Zannad F, Heymans S, Lyon AR
  The autonomic nervous system as a therapeutic target in heart failure: a scientific position statement from the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2017 Nov;19(11):1361-1378. doi: 10.1002/ejhf.921. Epub 2017 Sep 26.
•   Voils CI, Maciejewski ML, Hoyle RH, Reeve BB, Gallagher P, Bryson CL, Yancy WS Jr
  Initial validation of a self-report measure of the extent of and reasons for medication nonadherence. Med Care. 2012 Dec;50(12):1013-9. doi: 10.1097/MLR.0b013e318269e121.
•   Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group
  2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available. Erratum In: Eur Heart J. 2019 Feb 1;40(5):475.

Sham Controlled RCT Evaluating the Safety, Acceptability and Efficacy of Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Uncontrolled Hypertensive Patients: a Pilot Study

Details for clinical trial NCT05179343