Zapping nerves with ultrasound: a new hope for heart failure?
NCT ID NCT04719637
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.
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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
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6 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Aug 2024
- Lead sponsor
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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
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18 to 84 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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
-
Osaka University Hospital
Osaka, Japan
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Other studies related to the condition(s) this trial covers.
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