Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial

Azizi, Michel; Sapoval, Marc; Gosse, Philippe; Monge, Matthieu; Bobrie, Guillaume; Delsart, Pascal; Midulla, Marco; Mounier‐Véhier, Claire; Courand, Pierre‐Yves; Lantelme, Pierre; Denolle, Thierry; Dourmap-Collas, Caroline; Trillaud, Hervé; Pereira, Héléna; Plouin, Pierre‐François; Châtellier, Gilles

doi:10.1016/s0140-6736(14)61942-5

Cited by 475 publications

(375 citation statements)

References 30 publications

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“…Although recently reported results from the Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3) 14 and SYMPLICITY HTN-Japan (HTN-Japan) 15 clinical trials did not demonstrate superiority of RDN over pharmacological management of hypertension based on superiority analyses of office BP or 24-hour ambulatory BP measurements (ABPM), 14,15 further evaluation of the SYMPLICITY HTN-3 trial identified several potential confounding factors that may have impacted the overall results, including insufficient ablation attempts, insufficient 4-quadrant ablations, and antihypertensive medication changes. 16 In contrast to the results of SYMPLICITY HTN-3, the recently reported prospective Renal Denervation for Hypertension (DENER HTN) 17 trial reported small but statistically significant reductions in ambulatory BP (though not office or home BP) in denervated patients compared with a nonblinded, randomized control group of patients with resistant hypertension treated with a stepped-care pharmacological strategy. These reductions included greater decreases in both daytime and nighttime ambulatory systolic BP in the denervated group.…”

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confidence: 91%

Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure

et al. 2015

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U ncontrolled hypertension is associated with an increasing incidence of stroke, cardiovascular events such as myocardial infarction, peripheral artery disease, and end-stage renal disease across all ages, and ethnicities. [1][2][3][4][5] Detailed studies of blood pressure (BP) variability over 24 hours have further described an increased risk of cardiovascular events and stroke with elevated BP during the nighttime 6,7 and early morning hours. 8,9The sympathetic nervous system plays an active role in the modulation of BP, and its overactivation can lead to hypertension.10,11 Percutaneous catheter-based renal denervation (RDN) by radiofrequency ablation of the renal artery nerves has been shown to reduce central sympathetic activity 12,13 and BP in patients with uncontrolled hypertension. Although recently reported results from the Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3) 14 and SYMPLICITY HTN-Japan (HTN-Japan) 15 clinical trials did not demonstrate superiority of RDN over pharmacological management of hypertension based on superiority analyses of office BP or 24-hour ambulatory BP measurements (ABPM), 14,15 further evaluation of the SYMPLICITY HTN-3 trial identified several potential confounding factors that may have impacted the overall results, including insufficient ablation attempts, insufficient 4-quadrant ablations, and antihypertensive medication changes. 16In contrast to the results of SYMPLICITY HTN-3, the recently reported prospective Renal Denervation for Hypertension (DENER HTN) 17 trial reported small but statistically significant reductions in ambulatory BP (though not office or home BP) in denervated patients compared with a nonblinded, randomized control group of patients with resistant hypertension treated with a stepped-care pharmacological strategy. These reductions included greater decreases in both daytime and nighttime ambulatory systolic BP in the denervated group.Abstract-High nighttime and early morning blood pressure (BP) have been associated with greater risk for cardiovascular events than high clinic or daytime BP. BP is typically highest in the rising hours, when morning activities typically begin. We examined the effect of renal denervation on morning (6:00-8:59 AM), daytime (9:00 AM-8:59 PM), and nighttime ( P=0.28), but the classes prescribed and changes in prescription varied by study. Among patients treated with renal denervation, although the number of ablation treatments were similar in both studies (11.2±2.8 versus 11.5±1.9, P=0.55), patients in SYMPLICITY HTN-3 were less likely to receive at least 1 four-quadrant ablation treatment (25% versus 82%, P<0.001). In SYMPLICITY HTN-3, compared with controls (n=159), patients treated with renal denervation (n=325) experienced a significantly greater change in morning (−7.3±19.8 mm Hg, P<0.001) and nighttime (−6.1±18.2 versus −1.6±19.7 mm Hg, P=0.02) but not daytime systolic BP (−7.2±16.2 versus −6.4±18.6 mm Hg, P=0.67). This same trend was observed in the pooled analysis with HTN-Japan. Re...

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confidence: 91%

Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure

et al. 2015

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“…This strategy recently led to detect these forms in about half of the patients with resistant HT referred to tertiary centers [2], which is 50fold more than the current detection rate in common general clinical practice.…”

Section: Introductionmentioning

confidence: 99%

Prospective validation of an automated chemiluminescence-based assay of renin and aldosterone for the work-up of arterial hypertension

Rossi

Ceolotto

Rossitto

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background: The availability of simple and accurate assays of plasma active renin (DRC) and aldosterone con centration (PAC) can improve the detection of secondary forms of arterial hypertension. Thus, we investigated the performance of an automated chemiluminescent assay for DRC and PAC in referred hypertensive patients. Methods: We prospectively recruited 260 consecu tive hypertensive patients referred to an ESH Center for Hypertension. After exclusion of six protocol violations, 254 patients were analyzed: 67.3% had primary hyperten sion, 17.3% an aldosterone producing adenoma (APA), 11.4% idiopathic hyperaldosteronism (IHA), 2.4% reno vascular hypertension (RVH), 0.8% familial hyperaldo steronism type 1 (FH1), 0.4% apparent mineralocorticoid excess (AME), 0.4% a reninproducing tumor, and 3.9% were adrenalectomized APA patients. BlandAltman plots and Deming regression were used to analyze results. The diagnostic accuracy (area under the curve, AUC of the ROC) of the DRCbased aldosteronerenin ratio (ARR CL ) was compared with that of the PRAbased ARR (ARR RIA ) using as reference the conclusive diagnosis of APA.

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“…In contrast, the DENER-HTN study recently reported superiority of renal denervation over medical treatment alone in reducing ambulatory blood pressure. 11 Further clinical and preclinical trials of renal denervation are being conducted with hope that further light can be shed on how renal denervation can be utilized to benefit various pathophysiologic states.…”

Section: Introductionmentioning

confidence: 99%

Sub-acute Safety and Efficacy Evaluation of Single versus Double Treatment Cycles of a Monopolar Radiofrequency Catheter-Based Renal Nerve Ablation and its Chronic Evolution in a Large Animal Model

Hubbard¹,

Sakaoka²,

Brants³

et al. 2016

J.ATAMIS

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Aims:We aimed to evaluate the transcatheter renal denervation(RDN) effects delivered by a mono-electrode catheter in a large animal model including safety implications of delivery of one cycle versus two cycles of ablations.Methods and Results:18 animals underwent bilateral RDN; 4 untreated naïve swine were enrolled as controls for norepinephrine levels(NE) only. Animals recieved 120-second (follow up-7,30 and 90 days) or 240-second cycles ablations (follow up-7 days). Norepinephrine evaluation, histology and immunohistochemistry evaluation was performed. No luminal obstruction was observed at follow up. A 70% decrease in NE levels (76.68±57.87ng/g) was observed at 7 days, 81% at 30 days(49.05±45.81ng/g), and 51% at 90 days(12.7±73.2 ng/g) compared to naïve controls(254.1±54.1ng/g;p<0.05). Histologically, the thermal effect extended to a complete circumferential involvement with a depth ~8mm. The primary histological feature at 7 days was nerve necrosis and distal atrophy; at 30 days, necrosis was replaced by healing changes of fibrosis. Neuromatous regeneration was apparent at 30 days at RF treated levels. At 90 days these features progressed to become more conspicuous. There were no appreciable differences in depth and circumferential extent of RF injury between one and two cycle treatment groups.Conclusion:RDN performed with a mono-electrode catheter (Iberis) appears to be safe following single or double-cycle RF ablation.NE decrease following RDN was demonstrated at 7, 30, and 90 days compared to naïve controls, suggesting efficient nerve ablation with the device as intended for human use.

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Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial

Cited by 475 publications

References 30 publications

Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure

Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure

Prospective validation of an automated chemiluminescence-based assay of renin and aldosterone for the work-up of arterial hypertension

Sub-acute Safety and Efficacy Evaluation of Single versus Double Treatment Cycles of a Monopolar Radiofrequency Catheter-Based Renal Nerve Ablation and its Chronic Evolution in a Large Animal Model

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