JPRN-jRCT2032220027
Recruiting
未知
A clinical study of the ultrasonic renal denervation system (PRDS-001) in patients with hypertension - RADIANCE-HTN DUO
Kai Hisashi0 sites154 target enrollmentApril 16, 2022
ConditionsHypertension
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Kai Hisashi
- Enrollment
- 154
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who have received antihypertensive treatment with two antihypertensive drugs for at least 4 weeks prior to obtaining consent, with no change in the type or dosage
- •2\. 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
- •3\. 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
- •1\. Lacks appropriate renal artery anatomy for renal denervation
- •2\. Secondary hypertension other than sleep apnea
- •3\. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
- •4\. Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent
- •5\. 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
- •6\. 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
- •7\. 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
- •8\. Patients with a history of persistent or permanent atrial tachyarrhythmia
- •9\. Patients with active implantable medical devices
- •10\. Primary pulmonary hypertension
Outcomes
Primary Outcomes
Not specified
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