Effect of Renal Denervation on Stress, Hypertension and Anxiety Management

NCT05438446 | Unknown Phase 2

• 1 other identifier: ERSHAM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The ERSHAM (Effect of Renal Denervation on Stress, Hypertension and Anxiety Management) is a single-center, interventional, open-label, randomized controlled trial that will be conducted at the Hypertension Unit "ESH Excellence Center'', 1st Cardiology Department of the Medical School of the National and Kapodistrian University of Athens at the General Hospital of Athens "Hippokration", which is the reference center for uncontrolled hypertension and for sympathetic renal denervation (RDN) in our region. Sixty (60) consecutive patients aged 30-70 years with uncontrolled arterial hypertension either under anti-hypertensive treatment with 1 drug \[at least 50% of maximum manufacturer's recommended dosage of an angiotensin-converting enzyme inhibitor (ACEI)/ angiotensin II receptor blocker (ARB) or a calcium channel blocker (CCB)\] or naïve from antihypertensive treatment and HADS (Hospital anxiety and depression scale) anxiety subscore ≥ 8 will be enrolled (Figure 1). Patients will be randomized in a 1: 1 ratio to endovascular ultrasound RDN (Paradise renal denervation system, ReCor, CA, USA) (RDN) (n= 30) or to control group (n= 30). Baseline clinical data, cardiovascular risk factors, medical history as well as medication will be recorded in each group. After the randomization, patients who will be randomized to RDN group will undergo a computed tomography angiography (CTA) or magnetic resonance angiography (MRA) of the renal arteries in order to assess whether the renal arteries' anatomy is suitable for RDN by using the Paradise system. The images of the CTA/MRA will be uploaded onto BIOCLINICA web-based portal in order to optimize device use (RDN catheter) and location of ablations. Patients will not change their antihypertensive medications during the 3 months follow -up. After that, their management will be evaluated based on the current 2018 ESC/ESH guidelines. Possible RDN-related adverse events will be recorded during the follow-up period. Blood pressure (BP) will be measured by office BP measurements as well as 24-hour ambulatory blood pressure monitoring. Anxiety and depression will be evaluated by the self-assessment hospital anxiety and depression scale (HADS). Stress management will be evaluated via Perceived Stress Scale-14 (PSS-14). To assess the quality of life (QoL) the health status questionnaire (SF-12) will be used. The social readjustment rating scale will be used in order to evaluate the probability of developing a stress-related disorder during the follow-up period. Finally, a questionnaire for personal stress due to high blood pressure will be applied at the baseline and at the end of the follow-up period. Patients will be followed-up for 6 months after the randomization. A total of three (3) follow-up visits for each patient will be scheduled during the 6-month follow-up period of the study \[1st (adverse events review), 3rd, and 6th month after the randomization). If there is a failure in reaching the office BP \<140/90mmHg at the 3rd and 6th month, the antihypertensive therapy will be reevaluated according to the current ESH/ESC Guidelines. All patients will give written informed consent and the study will be organized according to ethical considerations, as described in the Declaration of Helsinki for human medical studies, and the protocol will be approved by the institutional medical ethics committee.

Conditions

Hypertension Arterial; Anxiety; Stress

Outcome Measures

Primary Outcomes (2)

• Anxiety 1

  Change in the Hospital Anxiety and Depression Scale (HADS) anxiety subscore

  From baseline (Screening Visit -1) at 3 months (Visit 2) of the follow-up period.

• Hypertension

  Change in the 24h systolic and diastolic blood pressure

  From baseline (Visit 0) at 3 months (Visit 2) of the follow-up period.

Secondary Outcomes (11)

• Anxiety 2

  From baseline (Screening Visit -1) at 6 months (Visit 3) of the follow-up period.

• Depression

  From baseline (Screening Visit -1) at 3 (Visit 2) and 6 months (Visit 3) of the follow-up period

• Stress

  From baseline (Visit 0) at 3 (Visit 2) and 6 months (Visit 3) of the follow-up period.

• Physical and Mental Health

  From baseline (Visit 0) at 3 (Visit 2) and 6 months (Visit 3) of the follow-up period.

• Office Blood Pressure 1

  From baseline (Visit 0) at 3 months (Visit 2) of the follow-up period.

Study Arms (2)

Renal Denervation Arm

EXPERIMENTAL

Endovascular ultrasound renal denervation (Paradise renal denervation system, ReCor, CA, USA) (RDN)

Procedure: Endovascular ultrasound renal denervation (Paradise renal denervation system, ReCor, CA, USA) (RDN)

Control

NO INTERVENTION

The patient will not receive any interventional therapy

Interventions

Endovascular ultrasound renal denervation (Paradise renal denervation system, ReCor, CA, USA) (RDN) PROCEDURE

The ReCor Medical Paradise® Renal Denervation System (Paradise System) is CE-marked in countries accepting the CE mark, but Investigational in the USA. The system is a catheter-based device designed to use ultrasound energy to thermally ablate the afferent and efferent nerves surrounding the renal artery and serving the kidney.

Renal Denervation Arm

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Office blood pressure (OBP) \>140/90mmHg and \<160/100 mmHg
• Either no baseline hypertension treatment or hypertension treatment with one drug. The antihypertensive treatment will include a renin-angiotensin system (RAS) blocker \[either an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB)\] or a calcium channel blocker (CCB).
• Unchanged antihypertensive therapy during the prior 8 weeks.
• Patients with baseline anxiety subscore ≥ 8 according to the Hospital Anxiety and Depression Scale (HADS)

You may not qualify if:

• Patients with secondary arterial hypertension or under treatment with b-blockers, diuretics, mineralocorticoid receptors antagonists (MRAs) or a centrally acting alpha-adrenergic agonist.
• Patients under treatment with antidepressants and/or anxiolytic drugs.
• Patients with a glomerular filtration rate (eGFR)\] \<45 ml / min / 1.73 m2 calculated using the CKD-EPI formula15.
• Patients with evidence of any of the following criteria on either renal artery side:
• Main renal artery diameter \< 3.0 mm or \> 8 mm
• Main renal treatable artery length \< 20 mm
• Presence of renal artery stenosis of any origin ≥ 30%
• Accessory arteries with diameter ≥ 2mm \<3.0 mm
• Calcification in renal arteries at location where energy is to be delivered
• A single functioning kidney
• Prior renal denervation procedure
• Presence of abnormal kidney tumors
• Renal artery with aneurysm
• Pre-existing renal stent or history of renal artery angioplasty
• Pre-existing aortic stent or history of aortic aneurysm

Sponsors & Collaborators

• Hippocration General Hospital: lead
• ReCor Medical, Inc.: collaborator

Study Sites (1)

Hippokration Hospital of Athens

Athens, Attica, 11527, Greece

RECRUITING

Related Publications (10)

• Tsioufis C, Ziakas A, Dimitriadis K, Davlouros P, Marketou M, Kasiakogias A, Thomopoulos C, Petroglou D, Tsiachris D, Doumas M, Skalidis E, Karvounis C, Alexopoulos D, Vardas P, Kallikazaros I, Stefanadis C, Papademetriou V, Tousoulis D. Blood pressure response to catheter-based renal sympathetic denervation in severe resistant hypertension: data from the Greek Renal Denervation Registry. Clin Res Cardiol. 2017 May;106(5):322-330. doi: 10.1007/s00392-016-1056-z. Epub 2016 Dec 12.

  PMID: 27957627 BACKGROUND

• Schmieder RE, Mahfoud F, Azizi M, Pathak A, Dimitriadis K, Kroon AA, Ott C, Scalise F, Mancia G, Tsioufis C; Members of the ESH Working Group on Interventional Treatment of Hypertension. European Society of Hypertension position paper on renal denervation 2018. J Hypertens. 2018 Oct;36(10):2042-2048. doi: 10.1097/HJH.0000000000001858.

  PMID: 30015759 BACKGROUND

• Papademetriou V, Doumas M, Tsioufis K. Renal Sympathetic Denervation for the Treatment of Difficult-to-Control or Resistant Hypertension. Int J Hypertens. 2011;2011:196518. doi: 10.4061/2011/196518. Epub 2011 Mar 30.

  PMID: 21629864 BACKGROUND

• Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23.

  PMID: 29803590 BACKGROUND

• Lenski D, Kindermann I, Lenski M, Ukena C, Bunz M, Mahfoud F, Bohm M. Anxiety, depression, quality of life and stress in patients with resistant hypertension before and after catheter-based renal sympathetic denervation. EuroIntervention. 2013 Oct;9(6):700-8. doi: 10.4244/EIJV9I6A114.

  PMID: 24169132 BACKGROUND

• Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.

  PMID: 30165516 BACKGROUND

• Venkataraman S, Vungarala S, Covassin N, Somers VK. Sleep Apnea, Hypertension and the Sympathetic Nervous System in the Adult Population. J Clin Med. 2020 Feb 21;9(2):591. doi: 10.3390/jcm9020591.

  PMID: 32098169 BACKGROUND

• Parati G, Ochoa JE, Lombardi C, Bilo G. Assessment and management of blood-pressure variability. Nat Rev Cardiol. 2013 Mar;10(3):143-55. doi: 10.1038/nrcardio.2013.1. Epub 2013 Feb 12.

  PMID: 23399972 BACKGROUND

• Seravalle G, D'Arrigo G, Tripepi G, Mallamaci F, Brambilla G, Mancia G, Grassi G, Zoccali C. Sympathetic nerve traffic and blood pressure changes after bilateral renal denervation in resistant hypertension: a time-integrated analysis. Nephrol Dial Transplant. 2017 Aug 1;32(8):1351-1356. doi: 10.1093/ndt/gfx200.

  PMID: 28810724 BACKGROUND

• Michopoulos I, Douzenis A, Kalkavoura C, Christodoulou C, Michalopoulou P, Kalemi G, Fineti K, Patapis P, Protopapas K, Lykouras L. Hospital Anxiety and Depression Scale (HADS): validation in a Greek general hospital sample. Ann Gen Psychiatry. 2008 Mar 6;7:4. doi: 10.1186/1744-859X-7-4.

  PMID: 18325093 BACKGROUND

MeSH Terms

Conditions

Hypertension; Anxiety Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Study Officials

• Konstantinos Tsioufis, MD, PhD

  Hippokration Hospital, Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panteleimon E Papakonstantinou, MD, MSc, PhD

CONTACT

+30 6948050600; pantelispapakon@gmail.com

Fotios Tatakis, MD

CONTACT

+30 6983128624; fotistatakis@yahoo.gr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Model Details: Single-center, prospective, interventional, 1:1 randomized controlled trial

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 30, 2022
• Study Start: October 18, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

GR (1)