NL-OMON54832招募中3 期
A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System* Kit, in Subjects with Hypertension. - The TARGET BP I Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
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
- •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. Subject is taking 2-5 antihypertensive medications (labeled for
- •hypertension) at time of enrollment, and is willing to adhere to a stable (no
- •change) medication regimen during the 4-week run-in period and 3 months
- •post-procedure. Antihypertensive medications must be as follows:
- •Two of the antihypertensive medications must be at least at 50% of their
- •maximally labelled dose prior to the planned procedure.
- •In subjects on 2 medications, one should be an ACE inhibitor or ARB, except
- •where subjects have documented intolerance to each of these drug classes.
- •All subjects must currently be taking, or have documentation that they failed
- •or cannot tolerate, a diuretic.
- •In the case of the thiazide agents hydrochlorothiazide and chlorthalidone,
- •12.5 mg would be acceptable as a minimum dose when used in combination with one
- •or more other antihypertensive medications.
- •For subjects on 2 non-diuretic antihypertensive medications, because they
- •either failed or have been unable to tolerate a diuretic, the 2 medications
- •should consist of any of the classes of antihypertensive agents listed below,
- •with the preferred choice of an ACE inhibitor or ARB and a CCB. In the latter
- •case, if both ACE inhibitor/ARB and CCB are contraindicated or not tolerated,
- •such reasons must be documented.
- •4. Subject meets blood pressure criteria at time of enrollment and prior to the
- •4-week run-in period: has 3 office blood pressure measurements with a mean
- •office SBP of >=150 mmHg and <=180 mmHg, AND a mean office DBP >=90 mmHg
- •5. Investigator judges that the subject can be managed safely during the 4-week
- •run-in period and 3 months post-procedure period without any changes to their
- •current antihypertensive medication regimen
- •6. Female subjects of childbearing potential must agree to use acceptable
- •methods of 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
- •End of run-in period
- •8. Subject has maintained the same antihypertensive medication regimen for at
- •least 4 weeks (28 days) prior to the procedure
- •9. Subject meets blood pressure criteria:
- •Has 3 office blood pressure measurements with a mean office SBP of >=150 mmHg
- •and <=180 mmHg AND mean office DBP >=90 mmHg AND
- •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 documented severe untreated obstructive sleep apnea
- •2. 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
- •3. Subject has a history of pre-eclampsia within the 5 years prior to study
- •4. Subject has orthostatic hypotension at baseline, or documented history of
- •orthostatic hypotension within 12 months prior to the planned procedure
- •5. Any contraindication to the imaging as required per the protocol.
- •6. Subject has imaging-assessed renal artery anatomy abnormalities or
- •variations based on investigator*s evaluation of the screening images (i.e.
- •MRA/CTA examination) meeting one of the following criteria:
- •Main renal artery that has a diameter of <3 mm or >7 mm and length of <5 mm
- •Accessory renal arteries with diameter <3 mm which supply >20% of the whole
- •kidney parenchyma on that side, per the investigator*s judgment
- •Subjects with more than one accessory renal artery per side supplying >20% of
- •the whole kidney parenchyma.
- •Renal artery stenosis >50% of the normal diameter segment
- •Any renal artery abnormality or disease that, per the physician assessment,
- •precludes the safe insertion of the guiding catheter
- •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
- •Previous renal denervation
- •Fibromuscular dysplasia of the renal arteries
- •7. Subject has a renal transplant, or is known to have a non-functioning kidney
- •or unequal renal size
- •8. Subject has a history of nephrectomy, a single kidney or kidney tumor, or
- •urinary tract obstruction
- •9. Subject has a history of recurrent kidney stones, or history of kidney
- •stones within 12 months prior to the planned procedure
- •10. Subject has an eGFR of <=45 mL/min/1.73 m2, based on the CKD-EPI equation;
- •or is on chronic renal replacement therapy
- •11. Subject has nephrotic syndrome
- •12. Subject for whom an ABPM device cannot be used due to arm size or other
- •reasons as identified by the investigator
- •13. Subject has any of the following conditions: severe cardiac valve stenosis,
- •heart failure (NYHA Class III or IV), atrial fibrillation (defined as at least
- •one documented episode in the 12 months before study entry), and known primary
- •pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic
- •14. Subject has an acute or sub-acute infection that the investigator judges
- •would pose unacceptable procedural risks to the subject
- •15. Subject has Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes
- •16. Subject has a contraindication known for conventional percutaneous
- •interventional procedures such as: intolerance for antiplatelet/anticoagulant
- •therapy, known hypersensitivity to contrast media that cannot be adequately
- •pre-medicated, bleeding/coagulation disorders, occlusive peripheral vascular
- •disease that would preclude percutaneous femoral access for the procedure
- •17. Subject has a known hypersensitivity to the neurolytic agent
- •18. Subject has a known history of substance (drug) use or alcohol dependen
研究者
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