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Effects of Electrical Baroreflex Stimulation on Sympathetic Activity, Renal Hemodynamics, and Insulin Sensitivity (CVRX-ReSy)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Hannover Medical School.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355510
First Posted: May 18, 2011
Last Update Posted: September 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hannover Medical School
  Purpose

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:

  1. Does chronic electrical stimulation of carotid baroreceptors inhibit sympathetic vasoconstrictor tone also in the long-term?
  2. 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.
  3. Does acute electrical baroreflex stimulation decrease renal vascular resistance?
  4. 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.

Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrical Baroreflex Stimulation - Sympathetic Activity

Further study details as provided by Hannover Medical School:

Estimated Enrollment: 30
Study Start Date: January 2011
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  • 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355510


Contacts
Contact: Jordan Jens, MD +495115322821 jordan.jens@mh-hannover.de
Contact: Reuter Julia, MD +495115322827 reuter.julia@mh-hannover.de

Locations
Germany
Hannover Medical School Recruiting
Hannover, Germany
Contact: Jens Jordan, MD    +495115322821    jordan.jens@mh-hannover.de   
Principal Investigator: Jens Jordan, MD         
Sub-Investigator: Julia Reuter, MD         
Sub-Investigator: Karsten Heusser, MD         
Sponsors and Collaborators
Hannover Medical School
  More Information

Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT01355510     History of Changes
Other Study ID Numbers: DE-MHH-CVRX-ReSy-EK5753
First Submitted: May 16, 2011
First Posted: May 18, 2011
Last Update Posted: September 19, 2013
Last Verified: September 2013