Effect Baroreflex Activation Therapy on the Carotid Body

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Hypertension Resistant To Conventional Therapy; Carotid Body; Baroreflex

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02210923

NL3770006813

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

20 participants in 1 patient group

Resistant hypertensive patients with Rheos system

Description:

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