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

Sponsor
Otsuka Medical Devices Co., Ltd. Japan (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04719637
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
50.3
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PRDS-001 Renal Denervation Ultrasound System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Actual Study Start Date :
Aug 24, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRDS-001

Renal denervation

Device: PRDS-001 Renal Denervation Ultrasound System
Renal Denervation Ultrasound System
Other Names:
  • renal denervation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MIBG-cardiac(washout rate) [6 months]

    Secondary Outcome Measures

    1. MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M) [6 months]

    2. Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing) [6 months]

    3. Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX [6 months]

    4. Peak oxygen uptake (peak VO2) assessed by CPX [6 months]

    5. Peak VO2/heart rate assessed by CPX [6 months]

    6. VE-VCO2 slope assessed by CPX [6 months]

    7. Peak respiratory exchange ratio assessed by CPX [6 months]

    8. Peak load assessed by CPX [6 months]

    9. Ramp duration assessed by CPX [6 months]

    10. Urinary noradrenalin concentration [6 months]

    11. NYHA class [6 months]

    12. MIBG-renal (washout rate) [6 months]

    13. MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M) [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 84 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osaka University Hospital Osaka Japan

    Sponsors and Collaborators

    • Otsuka Medical Devices Co., Ltd. Japan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Medical Devices Co., Ltd. Japan
    ClinicalTrials.gov Identifier:
    NCT04719637
    Other Study ID Numbers:
    • RDN-19-001
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Otsuka Medical Devices Co., Ltd. Japan
    Denervation
    Renal denervation
    Heart failure
    Ultrasound
    Cardiovascular Diseases
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Oct 5, 2021