EUCTR2018-000036-96-NL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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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. 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.
- •6. Female subjects of childbearing potential must agree to use acceptable methods of contraception (as defined in the protocol), 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 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).
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
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
- •11. Subject has a history of recurrent (>1 episode) kidney stones, or history of kidney stones within 12 months prior to the planned procedure
- •12. Subject has a history of nephrectomy, a single kidney or kidney tumor, or urinary tract obstruction (with potential for hydronephrosis).
- •13. Subject has a renal transplant, or is known to have a non-functioning kidney or unequal renal size (>2cm difference in renal length between kidneys associated with a chronic kidney disease or a deterioration of the kidney function)
- •14. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure
- •15. Subject has any of the following conditions: severe cardiac valvestenosis, heart failure (NYHA Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60mmHg PA
- •or RV systolic pressure)
- •16. Subject is allergic or intolerant to the neurolytic agent (dehydrated alcohol)
- •17. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed
- •18. Any contraindication to the imaging as required per the protocol
- •19. Subject for whom an ABPM device cannot be used due to arm size (>42cm arm circumference) or other reasons
- •20. Subject has any other acute or chronic condition that the Investigator believes will adversely affect the ability to interpret the data or will prevent the subject from completing the trial procedures, or has a life expectancy of <12 months
- •21. Subject has a known history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions, or for any reason, in the opinion of the Investigator, would be u
研究者
相似试验
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 MedicationsHigh blood pressure10057166hypertensionNL-OMON54821Ablative Solutions Inc50
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 MedicatioMedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersHypertensionEUCTR2018-000036-96-DEAblative 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 MedicatioMedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersHypertensionEUCTR2018-000036-96-GBAblative 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 MedicatioMedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersHypertensionEUCTR2018-000036-96-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 MedicatioMedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersHypertensionEUCTR2018-000036-96-BEAblative Solutions, Inc.400