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 range18 Years – 84 Years
SexALL
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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…