Chronic Heart FailureNCT04719637
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
A study testing PRDS-001 Renal Denervation Ultrasound System in people with Chronic Heart Failure, run by Otsuka Medical Devices Co., Ltd. Japan at 1 site in Japan.
Trial summary
The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- PRDS-001 Renal Denervation Ultrasound System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 24 Aug 2021to 7 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.
- Conditions
- Chronic Heart Failure
- Being tested
- PRDS-001 Renal Denervation Ultrasound System
- Keywords
- Denervation, Renal denervation, Heart failure, Ultrasound, Cardiovascular Diseases
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRDS-001 Renal Denervation Ultrasound SystemDevice
Also called renal denervation
Renal Denervation Ultrasound System
| Study group | Role | What they receive |
|---|---|---|
| PRDS-001 | Experimental | Renal denervation Receives: Device: PRDS-001 Renal Denervation Ultrasound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
MIBG-cardiac(washout rate)
Measured: 6 months
Secondary outcomes (13)
MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M)
Measured: 6 months
Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing)
Measured: 6 months
Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX
Measured: 6 months
Peak oxygen uptake (peak VO2) assessed by CPX
Measured: 6 months
Peak VO2/heart rate assessed by CPX
Measured: 6 months
VE-VCO2 slope assessed by CPX
Measured: 6 months
Peak respiratory exchange ratio assessed by CPX
Measured: 6 months
Peak load assessed by CPX
Measured: 6 months
Ramp duration assessed by CPX
Measured: 6 months
Urinary noradrenalin concentration
Measured: 6 months
NYHA class
Measured: 6 months
MIBG-renal (washout rate)
Measured: 6 months
MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start24 Aug 2021
- Primary completion16 Feb 2022
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Medical Devices Co., Ltd. Japan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719637
- Sponsor's protocol ID
- RDN-19-001
- Status last verified
- Nov 2024
- First submitted
- 16 Dec 2020
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04719637
- Acronym / sponsor ID
- RDN-19-001
- Conditions
- Chronic Heart Failure
- Keywords
- Denervation, Renal denervation, Heart failure, Ultrasound, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Otsuka Medical Devices Co., Ltd. JapanIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRDS-001 | Experimental | Device: PRDS-001 Renal Denervation Ultrasound SystemRenal denervation |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRDS-001 Renal Denervation Ultrasound SystemAlso: renal denervationRenal Denervation Ultrasound System | Device | PRDS-001 |
Primary outcome
MIBG-cardiac(washout rate)
Time frame: 6 months
13 secondary outcomes
MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M)
Time frame: 6 months
Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing)
Time frame: 6 months
Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX
Time frame: 6 months
Peak oxygen uptake (peak VO2) assessed by CPX
Time frame: 6 months
Peak VO2/heart rate assessed by CPX
Time frame: 6 months
VE-VCO2 slope assessed by CPX
Time frame: 6 months
Peak respiratory exchange ratio assessed by CPX
Time frame: 6 months
Peak load assessed by CPX
Time frame: 6 months
Ramp duration assessed by CPX
Time frame: 6 months
Urinary noradrenalin concentration
Time frame: 6 months
NYHA class
Time frame: 6 months
MIBG-renal (washout rate)
Time frame: 6 months
MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRDS-001 Renal Denervation Ultrasound System in people with Chronic Heart Failure, run by Otsuka Medical Devices Co., Ltd. Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIBG-cardiac(washout rate) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.