A clinical study of the ultrasonic renal denervation system (PRDS-001) in patients with hypertensio

Not Applicable

Recruiting

• Conditions: Hypertension

• Registration Number: JPRN-jRCT2032220027
• Lead Sponsor: Kai Hisashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 154

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
11. Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media
12. Night shift workers
13. Pregnant, nursing or planning to become pregnant
14. Patients with COVID-19 infection within 3 months prior to obtaining consent
15. Patients with any of the following central laboratory tests at screening
- Plasma aldosterone/renin ratio greater than or equal to 200 or plasma aldosterone greater than or equal to 60 pg/ml
- HbA1c greater than or equal to 8.0%
- eGFR less than 40 mL/min/1.73m^2

Study & Design

• Study Type: Interventional
• Study Design: Not specified