EUCTR2018-000036-96-DE
进行中（未招募）
1 期
A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects with Hypertension, in the Absence of Antihypertensive Medications - The TARGET BP OFF-MED Trial
概览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Prior to run\-in period:
- •1\. Subject has provided written informed consent.
- •2\. Male or female subject, aged \=18 and \=80 years at time of enrollment.
- •3\. If subject has a documented history of uncontrolled hypertension (see definition in Definition of Terms section of protocol) and is currently taking no (0\) antihypertensive medications, he/she must:
- •Have 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of \=140 mmHg and \=180 mmHg AND mean office diastolic blood pressure (DBP) \=90 mmHg, and
- •Be willing to adhere to the no\-medication regimen for at least 12 weeks (4\-week run\-in period and 8\-week post\-treatment period).
- •4\. If subject has a documented history of uncontrolled hypertension (see definition in Definition of Terms section of protocol) and is currently taking 1 or 2 antihypertensive medications, he/she must:
- •Have 3 office blood pressure measurements with a mean office SBP of \=120 mmHg and \=180 mmHg and
- •Be willing to discontinue his/her antihypertensive medication(s), and to adhere to the no\-medication regimen for at least 12 weeks (4\-week run\-in period and 8\-week post\-treatment period).
- •5\. Investigator judges that the subject can be discontinued safely from all current antihypertensive medication (where applicable) and managed safely for at least 12 weeks (4\-week run\-in period and 8\-week post\-treatment period) without antihypertensive medication intake.
排除标准
- •1\. Subject has a contraindication known for conventional percutaneous interventional procedures such as: Intolerance for antiplatelet/anticoagulant therapy, Known allergy to contrast media that cannot be adequately pre\-medicated, Bleeding/coagulation disorders (such as bleeding diathesis, thrombocytopenia, and severe anemia), Occlusive peripheral vascular disease that would preclude percutaneous femoral access for the procedure
- •2\. Subject has an acute or sub\-acute infection that the Investigator judges would pose unacceptable risks to the subject
- •3\. Subject has imaging\-assessed renal artery anatomy abnormalities or variations based on Investigator's evaluation of the screening images (i.e. MRA/CTA examination and/or renal angiography)
- •4\. Subject has documented severe untreated obstructive sleep apnea (AHI \=30 per hour)
- •5\. Subject has documented diagnosis of the following causes of hypertension: Cushing's disease or Cushing's Syndrome, hyperaldosteronism, pheochromocytoma, thyroid and parathyroid abnormalities, or onset of hypertension prior to the age of 18
- •6\. Subject has a history of pre\-eclampsia
- •7\. Subject has orthostatic hypotension at screening, or documented history of orthostatic hypotension within 12 months prior to the planned procedure, defined as a drop in blood pressure that is \>20mmHg in SBP and/or \>10mmHg in DBP within 3 minutes upon standing from sitting or from a lying down face\-up (supine) position
- •8\. Subject has Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus (defined as hemoglobin A1c \[HbA1c] \=9\.0%)
- •9\. Subject has an eGFR of \=45 mL/min/1\.73 m2, based on the CKD\-EPI equation; or is on chronic renal replacement therapy
- •10\. Subject has nephrotic syndrome
研究者
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进行中（未招募）
1 期
Study of the Effect of Kidney Denervation on Blood Pressure in Subjects with High Blood Pressure Without MedicatioHypertensionMedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-000036-96-NLAblative Solutions, Inc.400
进行中（未招募）
1 期
Study of the Effect of Kidney Denervation on Blood Pressure in Subjects with High Blood Pressure Without MedicatioHypertensionMedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-000036-96-IEAblative Solutions, Inc.400
进行中（未招募）
1 期
Study of the Effect of Kidney Denervation on Blood Pressure in Subjects with High Blood Pressure Without MedicatioHypertensionMedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2018-000036-96-BEAblative Solutions, Inc.400