Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Zapping nerves with ultrasound: a new hope for heart failure?

NCT ID NCT04719637

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study tested a device that uses ultrasound to calm overactive nerves near the kidneys (renal denervation) in 6 people with chronic heart failure. The goal was to see if it is safe and can improve heart function by reducing sympathetic nerve activity. Because it was a very small early study, the results are only a first step and need confirmation in larger trials.

What this could mean

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

Active substance
Ultrasound renal denervation device (PRDS-001)
What this could lead to
If successful, this approach could offer a new way to manage heart failure by calming overactive nerves, potentially reducing symptoms and improving heart function.
What could go wrong
This was a very small early study (only 6 patients) with no control group, so results are preliminary. The procedure carries risks like blood vessel damage, and it is unclear if benefits will hold in larger trials.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 84 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 : * Patients aged 18 years or older and younger than 85 years at the time of informed consent * NYHA (New York Heart Association) class II-III * More than 6 weeks have passed since onset of acute heart failure or acute exacerbation of chronic heart failure * Washout rate of MIBG \[3 (meta)-iodobenzylguanidine\] scintigraphy-cardiac is more than 35% * Patients having continued treatment of heart failure with the same dosage and administration for 4 weeks before obtaining informed consent Exclusion Criteria : * Patients with type1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (HbA1c: ≥ 8%) * Patients whose eGFR (estimated glomerular filtration rate) is less than 40 mL/min/1.73 m\^2 (estimation formula by Japanese Society of Nephrology) * Patients with concomitant or previous autoimmune or inflammatory bowel disease * Patients with a history of serious lung disease * Patients with a history of heart transplantation or VAD \[ventricle-assist device\] * Patients receiving reserpine, tricyclic antidepressants, and labetalol hydrochloride (can be used for up to 5 half-lives before informed consent is obtained) * Patients being treated for Parkinson's disease or Lewy body dementia * Patients with a history of any severe cardiovascular event (myocardial infarction, coronary artery bypass graft surgery, acute heart failure requiring hospitalization) or severe cerebrovascular event (stroke, transient ischemic event, cerebrovascular accident, etc.) within 3 months before obtaining informed consent * Patients with persistent atrial fibrillation * Patients using active implantable medical devices * Patients with coronary or carotid artery diseases who were deemed necessary by the principal investigator / sub investigator to undergo surgery or PCI (Percutaneous Coronary Intervention) within 6 months after obtaining informed consent * Patients with contraindications, unacceptable anaphylactic reactions, or uncontrollable allergies to contrast media * Female patients who are pregnant or breastfeeding * Patients whose office blood pressure (systolic) is 100mmHg or lower at the time of screening test

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic heart failure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Osaka University Hospital

    Osaka, Japan

More trials for these conditions

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