A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)

  • STATUS
    Recruiting
  • End date
    Dec 7, 2029
  • participants needed
    154
  • sponsor
    Otsuka Medical Devices Co., Ltd. Japan
Updated on 7 July 2022
hypertension
ace inhibitor
antihypertensive drugs
renal angiogram

Summary

To compare the antihypertensive effect of renal denervation with the Paradise™ system with that of a sham procedure in hypertensive patients receiving two antihypertensive drugs at the time of consent, and treated with a duo combination antihypertensive pill.

Details
Condition Hypertension, Vascular Diseases, Cardiovascular Diseases
Treatment Renal Angiogram, Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Clinical Study IdentifierNCT05326230
SponsorOtsuka Medical Devices Co., Ltd. Japan
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who have received antihypertensive treatment with two antihypertensive drugs (ARB/ACE inhibitor and Ca channel antagonist, either as a single agent or as a combination) for at least 4 weeks prior to obtaining consent, with no change in the type or dosage
Patients with a mean seated office blood pressure of between 140 mmHg and 180 mmHg systolic and between 90 mmHg and 110 mmHg diastolic at screening visit
Patients with a mean 24-hour ABPM (ambulatory blood pressure measurement) of between 130 mmHg and 170 mmHg systolic and between 80 mmHg and 105 mmHg diastolic at baseline visit

Exclusion Criteria

Lacks appropriate renal artery anatomy for renal denervation
Secondary hypertension other than sleep apnea
Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent
Repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent
Patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health
Patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period
Patients with a history of persistent or permanent atrial tachyarrhythmia
Patients with active implantable medical devices
Primary pulmonary hypertension
Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media
Night shift workers
Pregnant, nursing or planning to become pregnant
Patients with COVID-19 infection within 3 months prior to obtaining consent
Patients with any of the following central laboratory tests at screening
Plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml
HbA1c greater than or equal to 8.0%
eGFR less than 40 mL/min/1.73m2
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