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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

May 16, 2011
May 16, 2011
March 2011
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No Changes Posted
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Sympathetic Activity and Renal Denervation
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

Hypertension
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Brinkmann J, Heusser K, Schmidt BM, Menne J, Klein G, Bauersachs J, Haller H, Sweep FC, Diedrich A, Jordan J, Tank J. Catheter-based renal nerve ablation and centrally generated sympathetic activity in difficult-to-control hypertensive patients: prospective case series. Hypertension. 2012 Dec;60(6):1485-90. doi: 10.1161/HYPERTENSIONAHA.112.201186. Epub 2012 Oct 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
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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)
Both
18 Years and older
No
Contact: Heusser Karsten, MD +495115322723 heusser.karsten@mh-hannover.de
Contact: Reuter Julia, MD +495115322827 reuter.julia@mh-hannover.de
Germany
 
NCT01355055
DE-MHH-ReD-EK5853
No
PD Dr. med. Karsten Heusser, Hannover Medical School
Hannover Medical School
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Hannover Medical School
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP