NL-OMON46497撤回2 期
CALM-2 - Controlling and Lowering Blood Pressure with the MobiusHD* - CALM-2
Vascular Dynamics0 个研究点目标入组 33 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 33
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. Age 18 to 80
- •2. Mean Direct Observed Therapy (DOT) 24 hour ambulatory systolic blood pressure >=145 mmHg and <=200 mmHg and stable for at least 8 weeks on a maximally tolerated guideline directed Guideline directed *A+C+D* antihypertensive medication regimen, where *A* is an angiotensin-converting enzyme Inhibitor or an angiotensin receptor blocker, *C* is a calcium channel blocker, and *D* is a diuretic. Patients that have documented intolerance to one or more of these drugs and are on an alternative 3-5 drug regimen will be reviewed and approved by the Hypertension Committee prior to inclusion in the trial.
- •3. Antihypertensive medication compliance based on DOT-ABPM and HPLC/GCMS analysis of a urine sample
- •4. Two consecutive DOT 24-hour systolic DOT-ABPM measurements within 20% of each other
- •5. Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on carotid angiography.
排除标准
- •1. Known or clinically suspected baroreflex failure or autonomic neuropathy
- •2. History of hypertensive crisis in the past 6 months
- •3. Known significant aortoiliac or common femoral artery disease that will prohibit safe femoral access;
- •4. Hypertension secondary to an identifiable cause other than treated sleep apnea
- •(e.g., hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome, coarctation of the aorta, hyper- or hypothyroidism and intracranial tumor)
- •5. Currently taking centrally acting agonists such as clonidine, moxonidine, or methyl dopa;
- •6. Treatable cause of hypertension including, but not limited to, improper BP measurement, volume overload and pseudotolerance (excessive sodium intake, volume retention from kidney disease, inadequate diuretic therapy), drug-induced or other causes (non-adherence, inadequate doses, inappropriate combinations, NSAIDs, COX-2 inhibitors, cocaine, amphetamines, or other drugs, sympathomimetics, oral contraceptives (confirmed cause of hypertension), adrenocortical steroids, cyclosporine, tacrolimus, erythropoietin, excessive licorice (including some chewing tobacco), ephedra, ma haung, bitter orange; and excessive alcohol intake
- •7. Upper arm circumference >46 cm and/or BMI >=45 kg/m2
- •8. Chronic atrial fibrillation, or intermittent atrial fibrillation with one or more episode(s) within the last twelve (12) months
- •9. History of major bleeding complications associated with dual anti-platelet therapy
- •10. History of known uncorrected or uncorrectable bleeding diathesis
- •11. History of Heparin Induced Thrombocytopenia (HIT)
- •12. Current or planned use of chronic anticoagulation therapy including vitamin K antagonists and novel oral anticoagulants (apixaban, rivaroxaban, dabigatran and edoxaban)
- •13. Active gastritis or peptic ulcer disease with documented active ulcer or gastrointestinal bleeding within the last 3 months
- •14. History of allergy to nickel, or allergy to contrast media or study medications that cannot be managed medically
- •15. Persistent symptomatic orthostatic hypotension (>20/10 mmHg after 5 minutes of standing upright)
- •16. Syncope documented to be related to changes in blood pressure within the last six (6) months
- •17. History of myocardial infarction or unstable angina within the past six (6) months
- •18. History of cerebral vascular accident (stroke or TIA) within the past year or NIHSS >=5 or mRS >1 or any prior stroke with permanent neurologic defect or any prior intracranial bleed
- •19. Prior carotid surgery or stent placement, therapeutic radiation to the neck, or endovascular stent placement in either carotid region
- •20. Severe valvular or structural heart disease (excluding left ventricular hypertrophy)
- •21. Severe chronic obstructive pulmonary disease (requiring twenty-four-hour oxygen or chronic oral steroids), severe asthma, or severe pulmonary hypertension (Pulmonary Artery Systoic Pressure PASP>70 mmHg or Pulmonary Vascular Resistance PVR >4.0 Woods Units, not correctable with IV diuretics or vasodilator therapy)
- •22. NYHA class III or IV heart failure or known reduced left ventricular function
- •23. Uncontrolled diabetes mellitus with HbA1c >=10 %
- •24. Clinical suspicion or history of vasculitis or other condition causing vasculitis (e.g. autoimmune disorders)
- •25. Active infection within the last month requiring antibiotics
- •26. Uncontrolled co-morbi
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