JPRN-UMIN000036612已完成3 期
Global Clinical Study of Renal Denervation with the MDT-2115 multi-electrode renal denervation system in Patients with Uncontrolled Hypertension on Standard Medical Therapy - SPYRAL HTN-ON MED
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 257
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
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Individual has renal artery anatomy that is ineligible for treatment. 2. Individual has estimated glomerular filtration rate (eGFR) of <45. 3. Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus. 4. Individual has one or more episodes of orthostatic hypotension. 5. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. 6. Individual has primary pulmonary hypertension. 7. Individual is pregnant, nursing or planning to become pregnant. 8. Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment 9. Individual has one or more of the following conditions: stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time. Patients who received catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not excluded. 10. Individual works night shifts.
研究者
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