Cardiovascular Diseases, Hypertension, Vascular Diseases
Conditions
Keywords
Denervation, Hypertension
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.
Interventions
DEVICEParadise™ (PRDS-001) Renal Denervation Ultrasound System
Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control
DEVICERenal Angiogram
Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure
Sponsors
Otsuka Medical Devices Co., Ltd. Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in 24-hour systolic ABPM | From baseline to 3 months post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in 24-hour systolic ABPM | from baseline to 6 months post-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 |
| 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 |
| 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 who required a change in antihypertensive medication | at any time up to 12 months after the procedure |
| Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication | 3, 6, 12 months after the procedure |
| Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication | 3, 6, 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 heart rate in the office, home, ABPM | 3, 6, 12 months after the procedure |
Countries
Japan
Outcome results
None listed