Sympathetic Activity and Renal Denervation

NCT ID: NCT01355055

Last Updated: 2011-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hannover Medical School

Locations

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Hannover Medical School

Hanover, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Heusser Karsten, MD

Role: CONTACT

+495115322723

Reuter Julia, MD

Role: CONTACT

+495115322827

References

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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.

Reference Type DERIVED
PMID: 23045466 (View on PubMed)

Other Identifiers

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DE-MHH-ReD-EK5853

Identifier Type: -

Identifier Source: org_study_id

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