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

Otsuka Medical Devices

Status: Enrolling

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Treatments: Device: Renal Angiogram; Device: Paradise™ (PRDS-001) Renal Denervation Ultrasound System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05326230

RDN-21-002

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups

Renal Denervation

Experimental group

Description:

Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)

Treatment:

Device: Paradise™ (PRDS-001) Renal Denervation Ultrasound System

Sham Control

Sham Comparator group

Description:

Renal Angiogram

Treatment:

Device: Renal Angiogram