HypertensionCVRX-ReSyNCT01355510
Effects of Electrical Baroreflex Stimulation on Sympathetic Activity, Renal Hemodynamics, and Insulin Sensitivity
An observational study of Hypertension, run by Hannover Medical School at 1 site in Germany.
Trial summary
Electrical stimulation of carotid baroreceptors (baropacing) acutely decreases arterial pressure in patients with refractory hypertension. The reduction in blood pressure seems to be mediated through sympathetic inhibition with concomitant reduction in the activity of the renin-angiotensin system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with implanted devices for electrical baroreflex stimulation are recruited according to inclusion and exclusion criteria until good quality recordings have been obtained in 20 patients during both stimulator settings (ON and OFF) in the corresponding study arm. After obtaining written informed consent patients will be investigated in the laboratory.
Who may be able to join
- Subjects meeting all of the following criteria will be considered for enrollment in the study:
- Adult patients having an implanted device for electrical baroreflex stimulation.
- Signed written informed consent.
Who cannot join
- Subjects meeting all of the following criteria will be excluded from the study:
- ReSy Study - Protocol version: December 20, 2010 8
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Subject unlikely to comply with protocol, e. g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- Pregnancy. Breast-feeding.
Show all 9Show fewer
- History of hypersensitivity to inulin or paraaminohippurate or to drugs with a similar chemical structure have to be excluded from the constant-infusion procedure.
- History of drug or alcohol abuse.
- Blood donation of more than 500 mL during the previous 3 months (men) or 6 months (women).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover
Jens Jordan, MD, +495115322821, jordan.jens@mh-hannover.de
Jens Jordan, MD
About this study
Official title: Electrical Baroreflex Stimulation - Sympathetic Activity
Electrical stimulation of carotid baroreceptors (baropacing) acutely decreases arterial pressure in patients with refractory hypertension. The reduction in blood pressure seems to be mediated through sympathetic inhibition with concomitant reduction in the activity of the renin-angiotensin system. Indeed, switching on and off the stimulation is accompanied by decreases and increases in central sympathetic vasoconstrictor outflow, respectively. Plasma renin concentration also decreases with acute electrical baroreflex stimulation.
In some patients chronic baropacing is associated with long-term blood pressure reduction.
Read more
However, there is sparse information as to the relative contribution of blood pressure regulating systems to account for the acute and chronic effects of baropacing. Sympathetic, renal, and vascular mechanisms are of special interest. Furthermore, technical aspects of electrical baroreflex stimulation may play a role, e.g. worsening of the electrical contact between the stimulating electrodes and the baroreceptor afferents.
This study is designed to answer the following primary questions:
- Does chronic electrical stimulation of carotid baroreceptors inhibit sympathetic vasoconstrictor tone also in the long-term?
- Does sympathetic vasoconstrictor tone increase on switching off chronic baropacing? Such an increase would confirm electrical integrity of the system and proper contact to the baroreceptor afferents.
- Does acute electrical baroreflex stimulation decrease renal vascular resistance?
- Does acute electrical baroreflex stimulation influence glucose delivery to skeletal muscle and change insulin sensitivity? The study follows an open-label observational design and it is planned to recruit up to 30 patients over 3 years.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355510
- Sponsor's protocol ID
- DE-MHH-CVRX-ReSy-EK5753
- Acronym
- CVRX-ReSy
- Status last verified
- Sep 2013
- First submitted
- 16 May 2011
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Baroreflex Stimulation - Sympathetic Activity
- ClinicalTrials.gov ID
- NCT01355510
- Acronym / sponsor ID
- CVRX-ReSy / DE-MHH-CVRX-ReSy-EK5753
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 18 May 2011 (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.
Electrical stimulation of carotid baroreceptors (baropacing) acutely decreases arterial pressure in patients with refractory hypertension. The reduction in blood pressure seems to be mediated through sympathetic inhibition with concomitant reduction in the activity of the renin-angiotensin system. Indeed, switching on and off the stimulation is accompanied by decreases and increases in central sympathetic vasoconstrictor outflow, respectively. Plasma renin concentration also decreases with acute electrical baroreflex stimulation.
In some patients chronic baropacing is associated with long-term blood pressure reduction.
However, there is sparse information as to the relative contribution of blood pressure regulating systems to account for the acute and chronic effects of baropacing. Sympathetic, renal, and vascular mechanisms are of special interest. Furthermore, technical aspects of electrical baroreflex stimulation may play a role, e.g. worsening of the electrical contact between the stimulating electrodes and the baroreceptor afferents.
This study is designed to answer the following primary questions:
- Does chronic electrical stimulation of carotid baroreceptors inhibit sympathetic vasoconstrictor tone also in the long-term?
- Does sympathetic vasoconstrictor tone increase on switching off chronic baropacing? Such an increase would confirm electrical integrity of the system and proper contact to the baroreceptor afferents.
- Does acute electrical baroreflex stimulation decrease renal vascular resistance?
- Does acute electrical baroreflex stimulation influence glucose delivery to skeletal muscle and change insulin sensitivity? The study follows an open-label observational design and it is planned to recruit up to 30 patients over 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with implanted devices for electrical baroreflex stimulation are recruited according to inclusion and exclusion criteria until good quality recordings have been obtained in 20 patients during both stimulator settings (ON and OFF) in the corresponding study arm. After obtaining written informed consent patients will be investigated in the laboratory.
Key inclusion criteria (3 listed)
- Subjects meeting all of the following criteria will be considered for enrollment in the study:
- Adult patients having an implanted device for electrical baroreflex stimulation.
- Signed written informed consent.
Key exclusion criteria (9 listed)
- ReSy Study - Protocol version: December 20, 2010 8
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Subject unlikely to comply with protocol, e. g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- Pregnancy. Breast-feeding.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
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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.
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, run by Hannover Medical School at 1 site in Germany.
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 3 inclusion and 9 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 19 Sep 2013. 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 Germany. 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 Jordan Jens, MD (+495115322821, jordan.jens@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Sep 2013.