Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure (NCT04719637) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Japan6 participantsStarted 2021-08-24
Plain-language 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.
Who can participate
Age range
18 Years – 84 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 :
* 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.) wit…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.