Hypertension Resistant To Conventional TherapyNCT02210923
Effect Baroreflex Activation Therapy on the Carotid Body
An observational study of Hypertension Resistant To Conventional Therapy and Baroreflex, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Hypertension Resistant To Conventional Therapy, Baroreflex, Carotid Body
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center+
Maastricht, 6229 HX
Teba Alnima, MD, 0031 43 3875367, teba.alnima@mumc.nl
About this study
Official title: Carotid Baroreflex Activation and Its Effect on the Chemoreflex Study
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.
- Keywords
- Baroreflex, Electrical stimulation, Carotid body, Chemoreceptors, Resistant hypertension
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 times during different electrical activation settings within one hour
Secondary outcomes (7)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 - 1.25 hour
Change in forced expiratory volume-1 second (FEV1) before and after turning off the device
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startOct 2013
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension Resistant To Conventional TherapyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CVRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Abraham Kroon, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210923
- Sponsor's protocol ID
- NL3770006813
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Baroreflex Activation and Its Effect on the Chemoreflex Study
- ClinicalTrials.gov ID
- NCT02210923
- Acronym / sponsor ID
- NL3770006813
- Keywords
- Baroreflex, Electrical stimulation, Carotid body, Chemoreceptors, Resistant hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- CVRx, Inc.
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
7 secondary outcomes
Change in end-tidal CO2 during baroreflex activation therapy
Time frame: 1 - 1.25 hour
Change in blood pressure during baroreflex activation therapy
Time frame: 1 - 1.25 hour
Change in respiratory rate during baroreflex activation therapy
Time frame: 1 - 1.25 hour
Change in expiration time during baroreflex activation therapy
Time frame: 1 - 1.25 hour
Change in heart rate during baroreflex activation therapy
Time frame: 1 - 1.25 hour
Change in peripheral vascular resistance during baroreflex activation therapy
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Overall description of the device and related safety and efficacy resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Kroon, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension Resistant To Conventional Therapy and Baroreflex, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teba Alnima, MD (003143 3875367, teba.alnima@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arterial CO2 (PaCO2) during baroreflex activation therapy (time frame: 6 times during different electrical activation settings within one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.