CompletedPhase 2

Effect of Renal Denervation on Stress, Hypertension and Anxiety Management

Greece60 participantsStarted 2021-10-18

Plain-language 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.

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consecutive patients aged 30-70 years with arterial hypertension diagnosed at least 3 months prior to the inclusion. * 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) Exclusion Criteria: * 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 * Pr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at renal denervation — a procedure where nerves around the kidney arteries are treated — for both high blood pressure and anxiety at the same time. Could you help me understand whether there's good evidence that treating those kidney nerves might also reduce anxiety, and how confident researchers are in that connection?
2Since this is a Phase 2 trial that has now completed, what do the results so far tell us about whether renal denervation was safe and showed any real benefit for people dealing with both hypertension and anxiety together?
3Renal denervation is an invasive catheter-based procedure — how does the risk level of this kind of intervention compare to the blood pressure and anxiety medications I might already be a candidate for, especially given this was only a Phase 2 study?
4The trial specifically measured anxiety as a primary outcome — does that mean my anxiety would need to be significant to be relevant here, and would it be worth addressing my anxiety through a more established route like therapy or medication while we figure out the blood pressure side separately?
5Now that this trial is completed, is the data published or available anywhere, and are there follow-up Phase 3 studies planned that might give us a clearer picture before considering this approach?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anxiety 1

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

Trial details

NCT IDNCT05438446

SponsorHippocration General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-28

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