TY - JOUR
T1 - Renal denervation in resistant hypertension and obstructive sleep apnea
T2 - Randomized proof-of-concept phase II trial
AU - Warchol-Celinska, Ewa
AU - Prejbisz, Aleksander
AU - Kadziela, Jacek
AU - Florczak, Elzbieta
AU - Januszewicz, Magdalena
AU - Michalowska, Ilona
AU - Dobrowolski, Piotr
AU - Kabat, Marek
AU - Sliwinski, Pawel
AU - Klisiewicz, Anna
AU - Topor-Madry, Roman
AU - Narkiewicz, Krzysztof
AU - Somers, Virend K.
AU - Sobotka, Paul A.
AU - Witkowski, Adam
AU - Januszewicz, Andrzej
N1 - Funding Information:
This study was supported by the National Science Centre (grant No. NN 402 491140). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding Information:
E. Warchol-Celinska received nonfinancial support from Servier, Krka, and Medtronic outside the submitted work. A. Prejbisz received personal fees and nonfinancial support from Servier, Krka, Medtronic, Berin-Chemie/Menarini, Sanofi-Aventis, Polpharma, ResMed, and Gedeon Richter outside the submitted work. J. Kadziela received personal fees and nonfinancial support from Polpharma, St. Jude Medical, Astra Zeneca, and Medtronic outside the submitted work. E. Florczak received nonfinancial support from Servier and Egis outside the submitted work. P. Dobrowolski received nonfinancial support from Polpharma, Boehringer Ingelheim, and Servier outside the submitted work. M. Kabat received personal fees from Boehringer Ingelheim outside the submitted work. P. Sliwinski received personal fees and nonfinancial support from AstraZeneca, Boehringer Ingelheim, Chiesi, Grifols, Novartis, Roche, and Teva outside the submitted work. K. Narkiewicz received personal fees and nonfinancial support from Servier, Krka, Berin-Chemie/Menarini, Egis, Sandoz, Mylan, Polpharma, Adamed, and Gedeon Richter outside the submitted work. V.K. Somers is supported by a National Institutes of Health grant HL065176. He has served as a consultant for ResMed, Phillips, GlaxoSmithKline, Respicardia, Ronda Grey, Biosense Webster, Dane Garvin, Bayer, Itamar, and U-Health. He works with Mayo Health Solutions and their industry partners on intellectual property related to sleep and to obesity. P.A. Sobotka is an employee of ROX Medical, Inc, and a consultant to Symed and Cibiem. He receives no royalties from any inventions. A. Witkowski received speaker’s fees from Medtronic outside the submitted work. A. Januszewicz received personal fees and nonfinancial support from Servier, Krka, Medtronic, Berin-Chemie/ Menarini, Sanofi-Aventis, Polpharma, ResMed, and Gedeon Richter outside the submitted work. The other authors report no conflicts.
Publisher Copyright:
© 2018 American Heart Association, Inc.
PY - 2018
Y1 - 2018
N2 - It has been postulated that catheter-based renal denervation (RDN) may lower blood pressure (BP) and improve severity of obstructive sleep apnea (OSA) in resistant hypertensive patients. The aim of our study (NCT01366625) was to investigate in a prospective randomized trial the effect of RDN on BP and clinical course of OSA. Sixty patients with true resistant hypertension coexisting with moderate-to-severe OSA (apnea/hypopnea index, ≥15) were randomly allocated to RDN group (30 patients) and to control group (30 patients). The primary end point was reduction in office systolic BP at 3 months. Secondary end points included reduction in diastolic office and ambulatory BP, change in apnea/hypopnea index and biochemical measurements at 3 months, and change in echocardiographic measurements at 6 months. There were no differences in clinical characteristics between the groups. At 3 months in the RDN group, both office and ambulatory BP were significantly reduced, and a significant decrease in OSA severity (apnea/hypopnea index, 39.4 versus 31.2 events per hour; P=0.015) was observed. Between-group difference in apnea/hypopnea index change was significant at 0.05. At 6 months in the RDN group, reductions in office and ambulatory BP were sustained and were accompanied by significant improvement in echocardiographic measures of global longitudinal strain. There were no differences in metabolic variables in follow-up in both groups. In a randomized controlled trial, RDN lowered both office and ambulatory BP in patients with resistant hypertension and OSA. This was accompanied by improvement of the clinical severity of OSA.
AB - It has been postulated that catheter-based renal denervation (RDN) may lower blood pressure (BP) and improve severity of obstructive sleep apnea (OSA) in resistant hypertensive patients. The aim of our study (NCT01366625) was to investigate in a prospective randomized trial the effect of RDN on BP and clinical course of OSA. Sixty patients with true resistant hypertension coexisting with moderate-to-severe OSA (apnea/hypopnea index, ≥15) were randomly allocated to RDN group (30 patients) and to control group (30 patients). The primary end point was reduction in office systolic BP at 3 months. Secondary end points included reduction in diastolic office and ambulatory BP, change in apnea/hypopnea index and biochemical measurements at 3 months, and change in echocardiographic measurements at 6 months. There were no differences in clinical characteristics between the groups. At 3 months in the RDN group, both office and ambulatory BP were significantly reduced, and a significant decrease in OSA severity (apnea/hypopnea index, 39.4 versus 31.2 events per hour; P=0.015) was observed. Between-group difference in apnea/hypopnea index change was significant at 0.05. At 6 months in the RDN group, reductions in office and ambulatory BP were sustained and were accompanied by significant improvement in echocardiographic measures of global longitudinal strain. There were no differences in metabolic variables in follow-up in both groups. In a randomized controlled trial, RDN lowered both office and ambulatory BP in patients with resistant hypertension and OSA. This was accompanied by improvement of the clinical severity of OSA.
KW - Autonomic nervous system
KW - Humans
KW - Hypertension
KW - Sleep apnea, obstructive
KW - Therapeutics
UR - http://www.scopus.com/inward/record.url?scp=85054366167&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85054366167&partnerID=8YFLogxK
U2 - 10.1161/HYPERTENSIONAHA.118.11180
DO - 10.1161/HYPERTENSIONAHA.118.11180
M3 - Article
C2 - 29941516
AN - SCOPUS:85054366167
SN - 0194-911X
VL - 72
SP - 381
EP - 390
JO - Hypertension
JF - Hypertension
IS - 2
ER -