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Zapping kidney nerves may tame both hypertension and anxiety

NCT ID NCT05438446

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether a procedure called renal denervation — which uses ultrasound to calm overactive nerves around the kidneys — can lower blood pressure and reduce anxiety in people with uncontrolled hypertension. Sixty adults aged 30 to 70 with high blood pressure and elevated anxiety scores will be randomly assigned to receive the procedure or standard care. Researchers will track changes in blood pressure, anxiety, stress, and quality of life over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a catheter-based procedure that uses ultrasound energy to ablate nerves around the kidney arteries
What this could lead to
If it works, this could offer a new way to treat both high blood pressure and anxiety without daily medication.
What could go wrong
This is a small, early-phase trial with only 60 participants. The procedure involves risks like artery damage, and it is unclear if the anxiety benefit will be lasting or meaningful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Oct 2021

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 * Fibromuscular disease of the renal arteries * Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter * Patients with a history of acute coronary syndrome or stroke during the previous six months or Scheduled coronary interventional therapy during the next six months. * Patients with permanent atrial fibrillation, chronic heart failure and NYHA functional status II-IV, Cancer under therapy (radiotherapy, chemotherapy, immunotherapy) * Patients with life expectancy \<1 year (at the time of inclusion). * Pregnant women or women who are planning to become pregnant. * Patients who do not provide written consent to participate in the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hippokration Hospital of Athens

    Athens, Attica, 11527, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.