NL-OMON54821已完成2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
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
- 18 至 99（—）
入选标准
- •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
- •o Have 3 office blood pressure measurements with a mean office SBP of >=140 mmHg
- •and <=180
- •mmHg AND mean office DBP >=90 mmHg, and
- •o 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
- •o Have 3 office blood pressure measurements with a mean office SBP of >=120 mmHg
- •and <=180
- •o 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
- •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
- •6. Female subjects of childbearing potential must agree to use acceptable
- •contraception , from the time of informed consent through to the last
- •follow-up visit.
- •7. Subject agrees to have all study procedures performed and is able and
- •willing to comply with
- •all study follow-up visits and protocol requirements.
- •8. Subject has 3 office blood pressure measurements with a mean office SBP of
- •>=140 mmHg and
- •<=180 mmHg AND mean office DBP >=90 mmHg.
- •9. Subject has a mean 24-hour ambulatory SBP of >=135 mmHg and <=170 mmHg with
- •>=70% valid
- •readings (as determined by ABPM measurement device).
排除标准
- •1. Subject has a contraindication known for conventional percutaneous
- •interventional procedures.
- •2. Subject has an acute or sub-acute infection that the investigator judges
- •would pose unacceptable procedural 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) meeting one of the following
- •o Main renal artery that has a diameter of <4 mm or >7 mm and length of <5 mm
- •o Accessory renal arteries with diameter >2 mm or <4 mm, which supply >20% of
- •the whole kidney parenchyma on that side, per the investigator's judgment.
- •Note: subjects with more than one eligible accessory renal artery per side will
- •be excluded.
- •o Renal artery stenosis >50% of the normal diameter segment (diameter stenosis,
- •compared to the angiographically normal proximal or distal segment)
- •o Any renal artery abnormality or disease that, per the physician assessment,
- •precludes the safe insertion of the guiding catheter (including, but not
- •limited to, severe renal artery aneurysm, excessive tortuosity, severe renal
- •artery calcification)
- •o Previous renal angioplasty associated with stenting or other implants, that,
- •per the physician's assessment, precludes the safe deployment of the Peregrine
- •Catheter components in the target treatment segment of the renal artery
- •o Previous renal denervation
- •o Fibromuscular dysplasia of the renal arteries.
- •4. Subject has documented severe untreated obstructive sleep apnea
- •(apnea-hypopnea index [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 orthostatic hypotension at baseline, or documented history of
- •orthostatic hypotension within 12 months prior to the planned procedure,
- •defined as a drop in blood pressure that is >20 mmHg in SBP and/or >10 mmHg in
- •DBP within 3 minutes upon standing from sitting or from a lying down face-up
- •(supine) position.
- •7. Subject has Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes
- •mellitus (defined as hemoglobin A1c [HbA1c] >=9.0%). 8. Subject has an eGFR of
- •<=45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology
- •Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
- •9. Subject has nephrotic syndrome. 10. Subject has a history of nephrectomy, a
- •single kidney or kidney tumor, or urinary tract obstruction (with potential for
- •hydronephrosis). Note: Simple renal cysts are not an exclusion.
- •11. Subject has a renal transplant, or is known to have a non-functioning
- •kidney or unequal renal size 14. Subject has a history of myocardial
- •infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to
- •the planned procedure.
- •12. Subject has any of the following conditions: severe cardiac valve stenosis,
- •heart failure (New York Heart Association [NYHA] Class III or IV), chronic
- •atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg
- •pulmonary artery or right ventricular systolic pressure).
- •13. Subject has any other acute or chronic condition that the investigator
- 另有 1 项未显示
研究者
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