Status:
COMPLETED
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Lead Sponsor:
Otsuka Medical Devices Co., Ltd. Japan
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18-84 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04719637
Start Date
August 24 2021
End Date
August 7 2024
Last Update
November 8 2024
Active Locations (1)
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1
Osaka University Hospital
Osaka, Japan