Renal Denervation in Patients With Refractory Hypertension

NCT ID: NCT00753285

Last Updated: 2014-11-10

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

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Denervation

Group Type EXPERIMENTAL

Renal Denervation

Intervention Type DEVICE

Interventions

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Renal Denervation

Intervention Type DEVICE

Other Intervention Names

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Symplicity Renal Denervation System

Eligibility Criteria

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Inclusion Criteria

* Systolic blood pressure of 160 mmHg or greater
* On 3 or more antihypertensive medications
* eGFR \>= 45 mL/min

Exclusion Criteria

* Renal artery abnormalities
* Known secondary hypertension attributable to a cause other than sleep apnea
* MI, angina, CVA within 6 months
* Type 1 diabetes
* Others
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Vascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henry Krum, PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University and the Alfred Hospital

Locations

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Prairie Heart Institute

Springfield, Illinois, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Krum H, Schlaich MP, Sobotka PA, Bohm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7.

Reference Type DERIVED
PMID: 24210779 (View on PubMed)

Related Links

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http://www.medtronicrdn.com/index.htm

Medtronic Renal Denervation Program

Other Identifiers

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TP-040

Identifier Type: -

Identifier Source: org_study_id