EUCTR2016-002545-32-GB进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
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. 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 the 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, such doses should be 25 mg daily, reflecting the usual
- •maximum doses in contemporary medical practice when these diuretic agents are used in combination treatment. In countries where thiazide like agents are used in line with current local prescribing practice, these agents should also be administered at the usual maximum dose in contemporary medical practice when used in combination treatment.
- •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.
- •Note: The following classes of antihypertensive agents that would count towards the minimum number of agents are: ACE inhibitors, ARBs, CCBs, thiazide diuretics, loop diuretics, aldosterone antagonists, beta-blockers, centrally active agents, alpha receptor blockers, direct vasodilators, direct renin inhibitors, and hydralazine.
- •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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
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 age of 18
- •3. Subject has a history of pre-eclampsia
- •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 <4 mm or >7 mm and length of <5 mm
- •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
- •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), chronic atrial fibrillation, and known primary pulmonary hypertension
- •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 mellitus
- •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 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 dependence, or lacks the ability to comprehend or follow instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements
- •19. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids
- •20. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/transient ischemic attack (TIA) wi
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