[PP.05.40] CONTINUATION OF A RANDOMIZED DOUBLE-BLIND CONTROLLED TRIAL OF DISTAL RENAL DENERVATION VERSUS CONVENTIONAL MODE OF THE INTERVENTION FOR TREATMENT OF RESISTANT HYPERTENSION

Aim. To study the effectiveness of using the anatomically optimized distal renal denervation (RDN) in comparison with the standard approach for reducing myocardial damage and left ventricular (LV) hypertrophy in patients with resistant hypertension (HTN).Material and methods. The randomized double-blind study of the efficacy and safety of distal RDN compared to conventional main renal artery intervention (ClinicalTrials.gov NCT02667912) for the treatment of resistant HTN included 26 patients. All patients were divided into two groups: group 1 (n=16) — distal RDN, group 2 (n=10) — conventional RDN. In addition to 24-hour blood pressure (BP) monitoring, initially and 12 months after the intervention, contrast- enhanced cardiac magnetic resonance imaging was performed to determine the left ventricular mass and non-coronary myocardial damage area. All patients signed informed consent. Twenty-four patients completed the present study.Results. After 12 months, the mean 24-hour BP significantly decreased after both distal RDN (from 167,2±28,5/93,2±19,3 to 147,0±13,7/81,5±9,3 mm Hg (p<0,05)) and conventional RDN (from 157,5±22,5/90,6±23,9 to 139,9±17,7/80,0±16,7 (p<0,05)). Also in both cases, a trend to LV mass decrease was revealed: from 252,6±85,2 to 221,0±60,3 gm (p=0,096) after the distal RDN; from 214,3±54,1 to 186,4±48,1 gm (p=0,071) after the conventional RDN. In contrast, the myocardial damage area decreased only after distal RDN (from 2,33±1,33 to 1,35±0,67 cm3 (p=0,02)) and did not change after conventional RDN.Conclusion. In comparison with the conventional main renal artery intervention, distal RDN in patients with resistant HTN has an additional cardioprotective effect — a decrease in LV myocardial damage area.

Download Full-text

DURABLE STRONG EFFICACY AND FAVORABLE LONG-TERM RENAL SAFETY OF THE ANATOMICALLY OPTIMIZED DISTAL RENAL DENERVATION ACCORDING TO THE 3 YEAR FOLLOW-UP EXTENSION OF THE DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL

Heliyon ◽

10.1016/j.heliyon.2022.e08747 ◽

2022 ◽

pp. e08747

Author(s):

Stanislav Pekarskiy ◽

Andrei Baev ◽

Alla Falkovskaya ◽

Valeria Lichikaki ◽

Ekaterina Sitkova ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Renal Denervation ◽

Controlled Trial ◽

Double Blind ◽

Randomized Controlled ◽

Renal Safety

Download Full-text

Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2016-015672 ◽

2017 ◽

Vol 7 (9) ◽

pp. e015672 ◽

Cited By ~ 1

Author(s):

Zongjun Liu ◽

Li Shen ◽

Weijian Huang ◽

Xianxian Zhao ◽

Weiyi Fang ◽

...

Keyword(s):

Blood Pressure ◽

Resistant Hypertension ◽

Antihypertensive Medication ◽

Renal Denervation ◽

Controlled Trial ◽

Academic Community ◽

Chinese Patients ◽

Efficacy And Safety ◽

Primary Analysis ◽

Randomised Controlled

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.

Download Full-text