Clinical trial NCT04719637: Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Official title: Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Denervation
Renal denervation
Heart failure
Ultrasound
Cardiovascular Diseases
Lead sponsor: Otsuka Medical Devices Co., Ltd. Japan
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: MIBG-cardiac(washout rate)
timeFrame: 6 months
Secondary outcomes:
measure: MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M)
timeFrame: 6 months
measure: Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing)
timeFrame: 6 months
measure: Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX
timeFrame: 6 months
measure: Peak oxygen uptake (peak VO2) assessed by CPX
timeFrame: 6 months
measure: Peak VO2/heart rate assessed by CPX
timeFrame: 6 months
measure: VE-VCO2 slope assessed by CPX
timeFrame: 6 months
measure: Peak respiratory exchange ratio assessed by CPX
timeFrame: 6 months
measure: Peak load assessed by CPX
timeFrame: 6 months
measure: Ramp duration assessed by CPX
timeFrame: 6 months
measure: Urinary noradrenalin concentration
timeFrame: 6 months
measure: NYHA class
timeFrame: 6 months
measure: MIBG-renal (washout rate)
timeFrame: 6 months
measure: MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M)
timeFrame: 6 months
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka University Hospital
Study officials:
References: