@article{a4cfb2a79f054fc7b44c395c3357fa0a,
title = "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",
abstract = "Aims The randomized sham-controlled SPYRAL HTN-OFF MED trial demonstrated that renal denervation (RDN) using a multi-electrode catheter lowers ambulatory blood pressure (BP) in non-medicated hypertensive patients. The current report describes the effects of RDN on heart rate (HR) in this population. Methods and results Patients were enrolled with an office systolic BP (SBP) of >_150 mmHg and <180 mmHg, office diastolic BP (DBP) of >_90 mmHg, and a mean ambulatory SBP of >_140 mmHg and <170 mmHg. Patients were drug na{\"i}ve or removed from their anti-hypertensive medications. Eighty patients were randomized 1:1 to RDN or sham procedure. This post hoc analysis examines the effect at 3 months of RDN on HR and of high baseline 24-h HR on BP and HR changes. There was a significant reduction in 24-h HR at 3 months for the RDN group (-2.5 b.p.m.) compared with sham (-0.2 b.p.m.), P = 0.003 (analysis of covariance). Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026). RDN patients with baseline 24-h HR above the median (73.5 b.p.m.) had significant reductions in average ambulatory SBP (-10.7 mmHg difference, P = 0.001) and DBP (-7.5 mmHg, P < 0.001), whereas BP changes in RDN patients with below-median HRs were not significant. Conclusion Average and minimum morning HR were significantly reduced at 3 months for RDN compared with sham patients. A baseline 24-h HR above the median predicted greater BP reductions and may allow physicians to select patients likely to respond to the procedure.",
keywords = "Heart rate, Hypertension, Renal denervation",
author = "Michael B{\"o}hm and Felix Mahfoud and Townsend, {Raymond R.} and Kandzari, {David E.} and Stuart Pocock and Christian Ukena and Weber, {Michael A.} and Satoshi Hoshide and Manesh Patel and Tyson, {Crystal C.} and Joachim Weil and Tolga Agdirlioglu and Martin Fahy and Kazuomo Kario",
note = "Funding Information: Conflict of interest: Dr M.B. has received personal fees from Medtronic during the conduct of the study and honoraria for lectures and scientific advice from Abbott, AstraZeneca, Boehringer Ingelheim, Medtronic, Servier, and Vifor outside of the submitted work. Dr F.M. has received speaker honoraria and consultancy fees from St Jude Medical and Medtronic. Dr R.R.T. has reported institutional support for the conduct of clinical trials from Medtronic. Dr D.E.K. has received institutional support for the conduct of clinical trials from Medtronic and research or grant support and consulting honoraria for work unrelated to the present submission. Dr S.P. has received consultant fees from Medtronic during the conduct of the study. Dr C.U. has received speaker honoraria and consultant fees from Medtronic. Dr M.A.W. has received research or consultant fees from Medtronic, Boston Scientific, and ReCor outside the submitted work. Dr S.H. has received honoraria from Takeda Pharmaceutical Co. outside the submitted work. Dr M.P. is a consultant for Bayer, Jansen and Astra Zeneca and receives research grants from NHLBI, Bayer, Jansen, and Medtronic. Dr C.C.T. has reported institutional support for the conduct of clinical trials from Medtronic. Dr J.W. has received consulting honoraria from Medtronic. Dr T.A. has nothing to disclose. Mr M.F. is an employee of Medtronic. Dr K.K. has received institutional support for the conduct of clinical trials from Medtronic and received research funding from Teijin Pharma, Omron Healthcare, FUKUDA DENSHI, Bayer Yakuhin, A & D, Daiichi Sankyo, Mochida Pharmaceutical, EA pharma, Boehringer Ingelheim Japan, Tanabe Mitsubishi Pharma Corporation, Shionogi & Co., MSD KK, Sanwa Kagaku Kenkyusho, Bristol-Myers Squibb KK, Pfizer Japan, and Otsuka Holdings, and honoraria from Takeda Pharmaceutical, Daiichi Sankyo, Omron Healthcare, and Terumo outside the submitted work. Funding Information: The SPYRAL HTN-OFF MED trial was funded by Medtronic. Funder of the study, Medtronic, was responsible for selection of clinical sites in collaboration with an executive committee.",
year = "2019",
month = mar,
day = "1",
doi = "10.1093/eurheartj/ehy871",
language = "English",
volume = "40",
pages = "743--751",
journal = "European Heart Journal",
issn = "0195-668X",
publisher = "Oxford University Press",
number = "9",
}