Effect Baroreflex Activation Therapy on the Carotid Body

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Hypertension Resistant To Conventional Therapy Baroreflex Carotid Body

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Resistant hypertensive patients with Rheos system

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No