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

JRCT ID: jRCT2032220027

Registered date:16/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 13/07/2022
• Target sample size: 154
• Study type: Interventional

Intervention(s)

Renal denervation
A balloon catheter with ultrasound source (transducer) is inserted into the renal artery in order to ablate the renal sympathetic nerves surrounding the renal artery with frictional heat generated by ultrasound while protecting the arterial wall with cooling fluid inside of the balloon simultaneously.

Outcome(s)

• Primary Outcome: Primary endpoint: Mean change in 24-hour systolic ABPM from baseline to 3 months post-procedure

Secondary Outcome

- Important secondary endpoint
Mean change in 24-hour systolic ABPM from baseline to 6 months post-proceure

- Another secondary endpoints
1.Mean change in daytime/nighttime/24-hour ABPM (systolic/diastolic) from baseline to months 3, 6, and 12 post-procedure (excluding primary and important secondary endpoints)
2.Change in mean office blood pressure (systolic/diastolic) from baseline to months 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, and 60 post-procedure
3.Change in mean home blood pressure (systolic/diastolic) from baseline to months 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 60 post-procedure
4.Percentage of subjects with a mean decrease in daytime/nighttime/24-hour systolic ABPM of >=5 mmHg, >=10 mmHg, and >=15 mmHg at months 3, 6, and 12 post-procedure
5.Percentage of subjects who required a change in antihypertensive medication (addition, increase, decrease, or discontinuation) at any time up to 12 months after the procedure
6.Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication at 3, 6, and 12 months after the procedure
7.Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication at 3, 6 and 12 months after the procedure
8.Change from baseline in pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, and ABPM (at 3, 6, and 12 months after the procedure)
9.Change from baseline in heart rate in the office, at home, and ABPM at 3, 6, and 12 months after the procedure

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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 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

Related Information

• Primary Sponsor: Kai Hisashi
• Secondary ID(s): NCT05326230