CRT-607 ∗ Renal Denervation with a Percutaneous Bipolar Radiofrequency Balloon Catheter in Patients with Resistant Hypertension: Efficacy and Safety Results From the REDUCE-HTN Trial

IntroductionAvailable data show that approximately 8%–18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy.Methods and analysisThis is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population.Ethics and disseminationAll participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China.Trial registrationClinicalTrials.gov ID:NCT02900729; pre-results.

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Bipolar radiofrequency renal denervation with the Vessix catheter in patients with resistant hypertension: 2-year results from the REDUCE-HTN trial

Journal of Human Hypertension ◽

10.1038/jhh.2016.82 ◽

2017 ◽

Vol 31 (5) ◽

pp. 366-368 ◽

Cited By ~ 9

Author(s):

H Sievert ◽

◽

J Schofer ◽

J Ormiston ◽

U C Hoppe ◽

...

Keyword(s):

Resistant Hypertension ◽

Renal Denervation ◽

Bipolar Radiofrequency

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Efficacy and safety of renal denervation in elderly patients with resistant hypertension

Catheterization and Cardiovascular Interventions ◽

10.1002/ccd.25166 ◽

2015 ◽

Vol 86 (2) ◽

pp. 299-303 ◽

Cited By ~ 5

Author(s):

Ann-Kathrin Ziegler ◽

Stefan Bertog ◽

Benjamin Kaltenbach ◽

Dani Id ◽

Jennifer Franke ◽

...

Keyword(s):

Elderly Patients ◽

Resistant Hypertension ◽

Renal Denervation ◽

Efficacy And Safety

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Renal Denervation – a Modern Option for Treating Resistant Hypertension

Journal of Interdisciplinary Medicine ◽

10.2478/jim-2020-0002 ◽

2020 ◽

Vol 5 (1) ◽

pp. 19-22

Author(s):

Ioana Rodean ◽

Călin Chibelean

Keyword(s):

Risk Factors ◽

Blood Pressure ◽

Nervous System ◽

Cardiovascular Risk ◽

Resistant Hypertension ◽

Renal Denervation ◽

Efficacy And Safety ◽

Important Health ◽

Sympathetic Nervous ◽

New Treatment

AbstractHypertension is one of the main cardiovascular risk factors, and it remains an important health problem, demonstrating an increasing incidence despite new treatment methods. Numerous risk factors that can lead to the development of difficult-to-treat or resistant hypertension have been described in the literature in recent years. In this type of hypertension, an important role is played by the sympathetic nervous system. Especially in these cases, with a sympathetic overactivation, renal denervation has proven its efficacy and safety in lowering blood pressure. In this brief clinical update, we present the results of the main studies regarding the efficacy and safety of the renal denervation technique used in the treatment of resistant hypertension.

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TCT-426 Bipolar Radiofrequency Renal Denervation With The Vessix Balloon Catheter System: Preclinical Safety Evaluation Through 180 Days

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2014.07.475 ◽

2014 ◽

Vol 64 (11) ◽

pp. B125

Author(s):

Gregory J. Wilson ◽

Dawn Winsor-Hines ◽

Radhika R. Tunstall ◽

Barbara A. Huibregtse ◽

Liza Davis ◽

...

Keyword(s):

Renal Denervation ◽

Balloon Catheter ◽

Safety Evaluation ◽

Bipolar Radiofrequency ◽

Catheter System ◽

Preclinical Safety

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Renal Denervation for Uncontrolled and Resistant Hypertension: Systematic Review and Network Meta-Analysis of Randomized Trials

Journal of Clinical Medicine ◽

10.3390/jcm10040782 ◽

2021 ◽

Vol 10 (4) ◽

pp. 782

Author(s):

Jonathan Silverwatch ◽

Kristen E. Marti ◽

Mi T. Phan ◽

Hinali Amin ◽

Yuani M. Roman ◽

...

Keyword(s):

Blood Pressure ◽

Resistant Hypertension ◽

Renal Denervation ◽

Meta Analysis ◽

Pressure Effects ◽

Efficacy And Safety ◽

Comparative Efficacy ◽

Serious Adverse Events ◽

Main Renal Artery ◽

Meta Analyses

Comparative efficacy and safety of renal denervation (RDN) interventions for uncontrolled (UH) and resistant hypertension (RH) is unknown. We assessed the comparative efficacy and safety of existing RDN interventions for UH and RH. Six search engines were searched up to 1 May 2020. Primary outcomes were mean 24-h ambulatory and office systolic blood pressure (SBP). Secondary outcomes were mean 24-h ambulatory and office diastolic blood pressure (DBP), clinical outcomes, and serious adverse events. Frequentist random-effects network meta-analyses were used to evaluate effects of RDN interventions. Twenty randomized controlled trials (RCTs) (n = 2152) were included, 15 in RH (n = 1544) and five in UH (n = 608). Intervention arms included radiofrequency (RF) in main renal artery (MRA) (n = 10), RF in MRA and branches (n = 4), RF in MRA+ antihypertensive therapy (AHT) (n = 5), ultrasound (US) in MRA (n = 3), sham (n = 8), and AHT (n = 9). RF in MRA and branches ranked as the best treatment to reduce 24-h ambulatory, daytime, and nighttime SBP and DBP versus other interventions (p-scores: 0.83 to 0.97); significant blood pressure effects were found versus sham or AHT. RF in MRA+AHT was the best treatment to reduce office SBP and DBP (p-scores: 0.84 and 0.90, respectively). RF in MRA and branches was the most efficacious versus other interventions to reduce 24-h ambulatory SBP and DBP in UH or RH.

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