JPRN-jRCT2032220027招募中未知
A clinical study of the ultrasonic renal denervation system (PRDS-001) in patients with hypertension - RADIANCE-HTN DUO
Kai Hisashi0 个研究点目标入组 154 人开始时间: 2022年4月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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