Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure

Study Overview
=================
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.

Official Title
-----------------
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Device: PRDS-001 Renal Denervation Ultrasound System


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRDS-001<br>Renal denervation | Device: PRDS-001 Renal Denervation Ultrasound System<br>* Renal Denervation Ultrasound System<br>* Other names: renal denervation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MIBG-cardiac(washout rate) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M) |  | 6 months | 
| Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing) |  | 6 months | 
| Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX |  | 6 months | 
| Peak oxygen uptake (peak VO2) assessed by CPX |  | 6 months | 
| Peak VO2/heart rate assessed by CPX |  | 6 months | 
| VE-VCO2 slope assessed by CPX |  | 6 months | 
| Peak respiratory exchange ratio assessed by CPX |  | 6 months | 
| Peak load assessed by CPX |  | 6 months | 
| Ramp duration assessed by CPX |  | 6 months | 
| Urinary noradrenalin concentration |  | 6 months | 
| NYHA class |  | 6 months | 
| MIBG-renal (washout rate) |  | 6 months | 
| MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Diseases, Ultrasound, Denervation, Renal denervation, Heart failure