Effect Baroreflex Activation Therapy on the Carotid Body

Hypertension Resistant To Conventional Therapy Clinical Trial

Official title:

Carotid Baroreflex Activation and Its Effect on the Chemoreflex Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02210923
• Other study ID #: NL3770006813
• Status: Recruiting
• Phase: N/A
• First received: August 4, 2014
• Last updated: August 5, 2014
• Start date: October 2013

Study information

• Verified date: August 2014
• Source: Maastricht University Medical Center
• Contact: Teba Alnima, MD
• Phone: 003143 3875367
• Email: teba.alnima[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Baroreflex
• Carotid Body
• Coronary Vasospasm
• Hypertension
• Hypertension Resistant To Conventional Therapy

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	CVRx, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 times during different electrical activation settings within one hour	No
Secondary	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.	1 - 1.25 hour	No
Secondary	Change in blood pressure during baroreflex activation therapy	The change in cardiovascular variables will be analyzed during each device activation setting	1 - 1.25 hour	No
Secondary	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.	1 - 1.25 hour	No
Secondary	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.	1 - 1.25 hour	No
Secondary	Change in heart rate during baroreflex activation therapy	The change in cardiovascular variables will be analyzed during each device activation setting	1 - 1.25 hour	No
Secondary	Change in peripheral vascular resistance during baroreflex activation therapy	The change in cardiovascular variables will be analyzed during each device activation setting	1 - 1.25 hour	No
Secondary	Change in forced expiratory volume-1 second (FEV1) before and after turning off the device		2 hours	No

External Links

•   Overall description of the device and related safety and efficacy results