Carotid Baroreflex Activation and Its Effect on the Chemoreflex Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in arterial CO2 (PaCO2) during baroreflex activation therapy
研究概览
简要总结
Carotid baroreflex activation therapy (BAT) by the Rheos® system produces a sustained fall in blood pressure in patients with resistant hypertension. Since the activation electrodes are implanted at the level of the carotid sinus, it is conceivable that the nearby located carotid body chemoreceptors are stimulated as well. Physiological stimulation of carotid chemoreceptors not only raises respiration, but it also increases sympathetic activity which may in part counteract the effects of BAT. The aim of the present study is to investigate whether there is evidence for concomitant carotid chemoreflex activation during BAT. We hypothesized that there is no clinically relevant co-activation of the carotid body chemoreceptors during BAT in patients with resistant hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be currently implanted with Rheos system and have completed the 13-month follow-up period.
- •Be on stable anti-hypertensive therapy for at least 4 weeks prior to inclusion, where stable is defined as no changes in medications or dosage of medications.
- •Have at least one functional carotid baroreflex activation electrode.
- •Have signed and approved informed consent form for participation in this study.
排除标准
- •Myocardial infarction (MI) or cerebral vascular accident (CVA) within the past 90 days, or subject is still unstable from a prior MI or CVA that occurred more than 90 days ago.
- •Are unable or unwilling to comply with the protocol requirements of this study.
- •Diagnosed with severe chronic obstructive lung disease (COPD/asthma GOLD stadium III and IV).
结局指标
主要结局
Change in arterial CO2 (PaCO2) during baroreflex activation therapy
时间窗: 6 times during different electrical activation settings within one hour
During one hour several device activation settings will be programmed at random. During each device setting we will collect arterial blood samples to check for PaCO2.
次要结局
- Change in heart rate during baroreflex activation therapy(1 - 1.25 hour)
- Change in respiratory rate during baroreflex activation therapy(1 - 1.25 hour)
- Change in blood pressure during baroreflex activation therapy(1 - 1.25 hour)
- Change in expiration time during baroreflex activation therapy(1 - 1.25 hour)
- Change in end-tidal CO2 during baroreflex activation therapy(1 - 1.25 hour)
- Change in peripheral vascular resistance during baroreflex activation therapy(1 - 1.25 hour)
- Change in forced expiratory volume-1 second (FEV1) before and after turning off the device(2 hours)