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Sympathetic Activity and Renal Denervation (ReD)

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ClinicalTrials.gov Identifier: NCT01355055
Recruitment Status : Unknown
Verified March 2011 by Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : May 17, 2011
Last Update Posted : May 17, 2011
Information provided by:
Hannover Medical School

Brief Summary:

Primary hypothesis:

Catheter-based renal denervation reduces central sympathetic activation in patients with refractory hypertension.

Secondary hypotheses:

  1. The magnitude of the individual depressor response after catheter-based renal denervation depends on the extent of sympathoinhibition.
  2. Both, the reduction in arterial pressure and in central sympathetic activation are sustained over time up to 24±3 months after catheter-based renal denervation.
  3. Catheter-based renal denervation resets the sympathetic baroreflex to lower blood pressure values.

Condition or disease

Study Type : Observational
Estimated Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influences of Catheter-based Renal Denervation on Central Sympathetic Nervous System Regulation in Refractory Hypertension
Study Start Date : March 2011

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:   Probability Sample
Study Population
Patients with refractory hypertension, in whom catheter-based renal denervation is indicated and who are scheduled for this procedure, will be recruited from the outpatient clinic.

Inclusion Criteria:

  • Refractory hypertension (as defined by the WHO: poorly controlled hypertension (>140/90 mmHg) despite adequate doses of at least three antihypertensive drugs including a diuretic)
  • Men or women aged >18 years
  • Intact peroneal nerve
  • Written informed consent

Exclusion Criteria:

  • Diseases, dysfunctions, or medications (such as NET inhibitors) that exclude a participation in the study according to the investigator.
  • Legal incompetence or circumstances that interfere with the patient´s ability to fully understand scope, relevance, and/or consequences of participation in this study.
  • People in custody
  • hypersensitivity to clonidine, phenylephrine, or nitroprusside-sodium
  • sick sinus syndrome, second or third degree AV block, bradycardia < 50 bpm (contraindication for clonidine)
  • endogenous depression (contraindication for clonidine)

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): NCT01355055

Contact: Heusser Karsten, MD +495115322723 heusser.karsten@mh-hannover.de
Contact: Reuter Julia, MD +495115322827 reuter.julia@mh-hannover.de

Hannover Medical School Recruiting
Hannover, Germany
Principal Investigator: Karsten Heusser, MD         
Sub-Investigator: Julia Reuter, MD         
Sponsors and Collaborators
Hannover Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. med. Karsten Heusser, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01355055     History of Changes
Other Study ID Numbers: DE-MHH-ReD-EK5853
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases