Sympathetic Activity and Renal Denervation (ReD)

May 16, 2011 updated by: Hannover Medical School

Influences of Catheter-based Renal Denervation on Central Sympathetic Nervous System Regulation in Refractory Hypertension

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Hannover, Germany
        • Recruiting
        • Hannover Medical School
        • Principal Investigator:
          • Karsten Heusser, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Study Registration Dates

First Submitted

May 16, 2011

First Submitted That Met QC Criteria

May 16, 2011

First Posted (Estimate)

May 17, 2011

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE-MHH-ReD-EK5853

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe