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Sympathetic Activity and Renal Denervation (ReD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01355055
First received: May 16, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Estimated Enrollment: 26
Study Start Date: March 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hannover Medical School

Additional 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
Study First Received: May 16, 2011
Last Updated: May 16, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013