Clinical Trial: Effect Baroreflex Activation Therapy on the Carotid Body

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Carotid Baroreflex Activation and Its Effect on the Chemoreflex Study

Brief Summary: 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.

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome: Change in arterial CO2 (PaCO2) during baroreflex activation therapy [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in end-tidal CO2 during baroreflex activation therapy [ Time Frame: 1 - 1.25 hour ]
    Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.
  • Change in blood pressure during baroreflex activation therapy [ Time Frame: 1 - 1.25 hour ]
    The change in cardiovascular variables will be analyzed during each device activation setting
  • Change in respiratory rate during baroreflex activation therapy [ Time Frame: 1 - 1.25 hour ]
    Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.
  • Change in expiration time during baroreflex activation therapy [ Time Frame: 1 - 1.25 hour ]
    Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.
  • Change in heart rate during baroreflex activation therapy [ Time Frame: 1 - 1.25 hour ]
    The change in cardiovascular variables will be analyzed during each device activation setting
  • Change in peripheral vascular resistance during baroreflex activation therapy [ Time Frame: 1 - 1.25 hour ]
    The change in cardiovascular variables will be analyzed during each device activation setting
  • Change in forced expiratory volume-1 second (FEV1) before and after turning off the device [ Time Frame: 2 hours ]


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: August 4, 2014
Date Started: October 2013
Date Completion:
Last Updated: August 5, 2014
Last Verified: August 2014