ACTRN12615000780550终止未知
Effect of a sound wave vibration intervention on heart rate and blood pressure after triggering the sympathetic nervous system in healthy controls, healthy participants with elevated sympathetic activity and participants with early to mild hypertension.
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1. Between the ages of 18 and 50 years
- •2. Competent and willing to provide written, informed consent to participate in the study
- •Normal, healthy controls:
- •1. Free of any comorbidities
- •Healthy with elevated sympathetic activity:
- •1. Free of any comorbidities
- •2. Naturally high resting heart rate
- •3. May have previously been diagnosed with an anxiety disorder
- •Early to mild hypertension:
- •1. Documented diagnosis and treatment of hypertension within the last six months
- •2. Hypertension controlled by diet and exercise or no more than one anti-hypertensive medication
排除标准
- •1. Previous renal denervation or carotid barostimulation implant
- •2. History of a clavicle fracture as an adult (over 18 years)
- •3. Haemodynamically significant valvular heart disease for which, in the opinion of the Investigator, a significant reduction of BP is contraindicated
- •4.History of an implanted cardiac (e.g., implantable cardioverter-defibrillator, pacemaker, cardiac resynchronisation therapy) or neurostimulation device
- •5. History of having undergone any type of cardiac surgery including coronary artery bypass graft and/or valve surgery
- •6. History of stent grafting
- •7. Known secondary causes of hypertension or primary pulmonary hypertension
- •8. Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
- •9. Known or suspected baroreflex failure or significant orthostatic hypotension (one or more episodes in the past year not related to medications. Defined as reduction in SBP of equal to or more than 20mmHg or diastolic blood pressure (DBP) equal to or more than 10 mmHg within three minutes of standing).
- •10. One or more hospital admissions for a hypertensive crisis within the past year. Hypertensive crisis is defined as severely elevated BP [greater than 180/110 mmHg] that is not related to confirmed non-adherence with medications, together with progressive or impending target organ damage, requiring hospitalization and typically admission to the intensive care unit
- •11. History of a myocardial infarction, unstable angina, or documented multi-vessel coronary artery disease
- •12. History of syncope, transient ischemic attack and/or cerebral vascular accident within the last 6 months
- •13. Subject with atrial fibrillation, supraventricular tachycardia, or other documented sustained arrhythmias that required hospitalization within the last 6 months
- •14. Type 1 diabetes mellitus
- •15. Chronic renal disease requiring dialysis
- •16. Kidney or liver transplant
- •17. Females who are pregnant
研究者
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