NL-OMON47214已完成2 期
Controlling And Lowering blood pressure with the MobiusHD device: STudying effects in A Randomized Trial. - CALM-START
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
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. Aged 18-70 years;
- •2. Diagnosed with resistant hypertension;
- •3. A mean systolic 24-hour ambulatory blood pressure of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).;Baseline:
- •1. A mean systolic 24-hour ambulatory blood pressure of 135-170 mmHg after washout of all antihypertensive medications.
排除标准
- •1. An inability to provide written informed consent;
- •2. Taking more than 4 antihypertensive medications;
- •3. Taking medications co-indicated for hypertension and a comorbidity that cannot be safely stopped for the antihypertensive medication washout periods (examples include beta-blockers) or taking other medications that cause hypotension (i.e. SGLT2 inhibitors for the treatment of diabetes mellitus) that cannot be safely switched/stopped;
- •4. Currently taking centrally acting agonists such as clonidine, moxonidine, or methyl dopa;
- •5. White coat hypertension, defined as >20% difference between an average of 3 consecutive systolic OBP measurements and mean systolic 24-hour ABP;
- •6. Patient with a history of hypertensive crisis in the past 6 months;
- •7. Known or clinically suspected baroreflex failure or autonomic neuropathy;
- •8. Known significant aortoiliac or common femoral artery disease that will prohibit safe femoral access, or determination upon femoral pulse assessment and examination of inguinal anatomy that femoral access is contraindicated;
- •9. 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);
- •10. 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;
- •11. Arm circumference >46 cm and/or BMI >=40 kg/m2;
- •12. Chronic atrial fibrillation, or intermittent atrial fibrillation with one or more episode(s) within the last twelve (12) months;
- •13. History of bleeding complications with dual antiplatelet therapy in the past, or has known uncorrected bleeding diathesis, or has history of Heparin Induced Thrombocytopenia (HIT);
- •14. Current or planned use of chronic anticoagulation therapy, including vitamin K antagonists and novel oral anticoagulants (apixaban, rivaroxaban, dabigatran and edoxaban).
- •15. Peptic ulcer disease with documented active ulcer, or gastrointestinal bleeding within the last year;
- •16. History of allergy to nickel, or allergy to contrast media that cannot be managed medically;
- •17. Persistent symptomatic orthostatic hypotension (>20/10 mmHg after 5 minutes of standing upright);
- •18. Syncope documented to be related to changes in BP within the last six (6) months;
- •19. History of myocardial infarction, or unstable angina within the past six (6) months;
- •20. History of cerebral vascular accident within the past year, and NIHSS >5 or mRS >1, or any prior stroke with permanent neurologic defect or any intracranial bleed;
- •21. Chronic kidney disease (Glomerular filtration rate (GFR) calculated by the Modification of Diet in Renal Disease equation <45 ml/min);
- •22. Prior carotid surgery, therapeutic radiation, or endovascular stent placement in either carotid region;
- •23. Severe v
研究者
相似试验
尚未招募
不适用
Reduction of Uncontrolled Hypertension by Remote Monitoring and Telemedicine (REMOTE) StudyhypertensionJPRN-UMIN000028937Tokyo Women's Medical University Department of Internal Medicine II, Endocrinology and Hypertension444
招募中
不适用
strategy for adequate blood pressure lowering in the patients with intracranial atherosclerosisDiseases of the nervous systemKCT0000351Asan Medical Center140
进行中（未招募）
不适用
Study of the efficacy of two blood pressure lowering drugs, ramipril and nifedipine GITS, in reducing the variability of blood pressure in patients with high blood pressure.EUCTR2014-003459-76-GRIstituto Auxologico Italiano, IRCCS168
进行中（未招募）
1 期
Study of the efficacy of two blood pressure lowering drugs, ramipril and nifedipine GITS, in reducing the variability of blood pressure in patients with high blood pressure.essential hypertensionMedDRA version: 17.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2014-003459-76-ITIstituto Auxologico Italiano, IRCCS168
进行中（未招募）
1 期
Effect of strategy for blood pressure control on cerebral oxygen balance during aortic coarctation repair: a randomized studyaortic coarctation requiring surgical correctionMedDRA version: 9.1Level: LLTClassification code 10002894Term: Aortic coarctationEUCTR2007-002640-19-BEniversity Hospital Gent