We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sympathetic Activity and Renal Denervation (ReD)

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 March 2011 by Hannover Medical School.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355055
First Posted: May 17, 2011
Last Update Posted: May 17, 2011
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:
Hannover Medical School
  Purpose

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
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influences of Catheter-based Renal Denervation on Central Sympathetic Nervous System Regulation in Refractory Hypertension

Further study details as provided by Hannover Medical School:

Estimated Enrollment: 26
Study Start Date: March 2011
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
Criteria

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)
  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): NCT01355055


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

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

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 Submitted: May 16, 2011
First Posted: May 17, 2011
Last Update Posted: May 17, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases


To Top