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Eur Heart J. 2019 Mar 1;40(9):743-751. doi: 10.1093/eurheartj/ehy871.

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.

Author information

1
Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Kirrberger Street 1, Homburg/Saar, Germany.
2
Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, USA.
3
Department of Interventional Cardiology, Piedmont Heart Institute, 275 Collier Rd NW #500, Atlanta, GA, USA.
4
Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel St, Bloomsbury, London, UK.
5
Department of Medicine, SUNY Downstate College of Medicine, 450 Clarkson Ave, Brooklyn, NY, USA.
6
Department of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Tochigi-ken, Japan.
7
Department of Cardiology, Duke University Medical Center, 2301 Erwin Road, Durham, NC, USA.
8
Department of Internal Medicine, Duke University Medical Center, 2301 Erwin Road, Durham, NC, USA.
9
Department of Cardiology, Sana Cardiomed Heart Center, Kronsforder Allee 71, Lübeck, Germany.
10
Medtronic PLC, Santa Rosa, CA, USA.

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 naïve 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

PMID:
30608521
DOI:
10.1093/eurheartj/ehy871

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