Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial. Issue 8 (August 2016)

• Record Type: Journal Article
• Authors: Mathiassen, Ole N.; Vase, Henrik; Bech, Jesper N.; Christensen, Kent L.; Buus, Niels H.; Schroeder, Anne P.; Lederballe, Ole; Rickers, Hans; Kampmann, Ulla; Poulsen, Per L.; Hansen, Klavs W.; B⊘tker, Hans E.; Peters, Christian D.; Engholm, Morten; Bertelsen, Jannik B.; Lassen, Jens F.; Langfeldt, Sten; Andersen, Gratien; Pedersen, Erling B.; Kaltoft, Anne
• Is Part Of: Journal of hypertension. Volume 34:Issue 8(2016:Aug.)
• Publication Date: 2016-08
• Subjects: ambulatory blood pressure measurement -- randomized controlled trial -- renal denervation -- SHAM procedure -- treatment-resistant hypertension; Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/HJH.0000000000000977
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Background: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. Method: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145 mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). Results: We randomized 69 patients with treatment-resistant hypertension to RDN ( n = 36) or SHAM ( n = 33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159 ± 12 mmHg (RDN) and 159 ± 14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [−6.2 ± 18.8 mmHg (RDN) vs. −6.0 ± 13.5 mmHg (SHAM)] and at 6 months [−6.1 ± 18.9 mmHg (RDN) vs. −4.3 ± 15.1 mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8 ± 2.7 (RDN) vs. 7.0 ± 2.5 (SHAM)]. RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. Conclusion: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.