NCT05326230Active, not recruitingNot Applicable
A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension
Otsuka Medical Devices Co., Ltd. Japan93 sites in 1 country154 target enrollmentStarted: July 1, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 154
- Locations
- 93
- Primary Endpoint
- Mean change in 24-hour systolic ABPM
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Renal Denervation
Experimental
Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)
Intervention: Paradise™ (PRDS-001) Renal Denervation Ultrasound System (Device)
Sham Control
Sham Comparator
Renal Angiogram
Intervention: Renal Angiogram (Device)
Outcomes
Primary Outcomes
Mean change in 24-hour systolic ABPM
Time Frame: From baseline to 3 months post-procedure
Secondary Outcomes
- Percentage of subjects with a mean decrease in daytime/nighttime/24-hour systolic ABPM of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg(3, 6, and 12months post-procedure)
- Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication(3, 6, 12 months after the procedure)
- Change in mean heart rate in the office, home, ABPM(3, 6, 12 months after the procedure)
- Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints)(From baseline to 3, 6, 12 months post-procedure)
- Mean change in 24-hour systolic ABPM(from baseline to 6 months post-procedure)
- Change in mean sitting office blood pressure (systolic/diastolic)(From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure)
- Percentage of subjects who required a change in antihypertensive medication(at any time up to 12 months after the procedure)
- Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM(3, 6, 12 months after the procedure)
- Change in mean home blood pressure (systolic/diastolic)(From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure)
- Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication(3, 6, 12 months after the procedure)
- Change in mean sitting office blood pressure (systolic/diastolic)(From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure)
- Change in mean home blood pressure (systolic/diastolic)(From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure)
Investigators
Study Sites (93)
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