Native Kidney Denervation in Patients With End Stage Renal Disease

NCT ID: NCT00551304

Last Updated: 2012-11-06

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

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ardian Catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* adult \>= 18 years of age
* end stage renal disease, undergoing concurrent dialysis treatment
* poorly controlled blood pressure on at least 2 antihypertensive drugs
* agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits
* competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria

* renal arterial abnormalities
* myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months
* hemodynamically significant valvular heart disease
* implantable cardioverter defibrillator (ICD) or pacemaker
* respiratory support.
* pregnant, nursing or planning to be pregnant
* other
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Vascular

INDUSTRY

Sponsor Role lead

Principal Investigators

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Markus Schlaich, MD

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Locations

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The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

John Paull II Hosptial

Krakow, , Poland

Site Status

Countries

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Australia Poland

References

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Schlaich MP, Hering D, Sobotka PA, Krum H, Esler MD. Renal denervation in human hypertension: mechanisms, current findings, and future prospects. Curr Hypertens Rep. 2012 Jun;14(3):247-53. doi: 10.1007/s11906-012-0264-9.

Reference Type DERIVED
PMID: 22457244 (View on PubMed)

Hering D, Esler MD, Krum H, Mahfoud F, Bohm M, Sobotka PA, Schlaich MP. Recent advances in the treatment of hypertension. Expert Rev Cardiovasc Ther. 2011 Jun;9(6):729-44. doi: 10.1586/erc.11.71.

Reference Type DERIVED
PMID: 21714604 (View on PubMed)

Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.

Reference Type DERIVED
PMID: 19822798 (View on PubMed)

Other Identifiers

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TP-020 & TP-039

Identifier Type: -

Identifier Source: org_study_id