An observational study in Hypertension Resistant To Conventional Therapy, Baroreflex and Carotid Body, sponsored by Maastricht University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-08-07.
Sponsored by Maastricht University Medical Center · Observational
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.
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This study's planned enrollment of 20 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
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Subjects implanted with a BAT system will be invited to participate in this study. These are patients who were enrolled in the DEBuT-HET and Rheos Pivotal Trial and have given their permission to be approached for follow-up studies. Subjects are all >21 years of age and were all known with a blood pressure ≥160/90 mmHg despite optimal antihypertensive therapy before receiving BAT. It is essential to have the Rheos® device implanted to enable participation in this study, as we want to investigate the effect of electrical carotid sinus activation on the carotid body chemoreflex.
Exclusion Criteria:
We will program 6 electrical device activation setting twice in a random order to see what happens with the aforementioned respiratory and cardiovascular variables. The following electrical settings will be programmed for 4 minutes each setting: * 20 Hz, 3 Volts, 480 microseconds * 20 Hz, 6 Volts, 480 microseconds * 50 Hz, 3 Volts, 480 microseconds * 50 Hz, 6 Volts, 480 microseconds * 90 Hz, 3 Volts, 480 microseconds * 90 Hz, 6 Volts, 480 microseconds
Change in arterial CO2 (PaCO2) during baroreflex activation therapy
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.
Time frame: 6 times during different electrical activation settings within one hour
Change in end-tidal CO2 during baroreflex activation therapy
Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.
Time frame: 1 - 1.25 hour
Change in blood pressure during baroreflex activation therapy
The change in cardiovascular variables will be analyzed during each device activation setting
Time frame: 1 - 1.25 hour
Change in respiratory rate during baroreflex activation therapy
Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.
Time frame: 1 - 1.25 hour
Change in expiration time during baroreflex activation therapy
Change in respiratory variables will be analyzed during the aforementioned time frame in which we will program several device activation settings.
Time frame: 1 - 1.25 hour
Change in heart rate during baroreflex activation therapy
The change in cardiovascular variables will be analyzed during each device activation setting
Time frame: 1 - 1.25 hour
Change in peripheral vascular resistance during baroreflex activation therapy
The change in cardiovascular variables will be analyzed during each device activation setting
Time frame: 1 - 1.25 hour
Change in forced expiratory volume-1 second (FEV1) before and after turning off the device
Time frame: 2 hours
This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center