Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation

NCT ID: NCT01899456

Last Updated: 2015-11-05

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-11-30

Brief Summary

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The study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter.

Detailed Description

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Conditions

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Hypertension Chronic Kidney Disease Renal Transplantation Sympathetic Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medical therapy

Best medical therapy using guideline recommended drugs in each disease state.

Group Type NO_INTERVENTION

No interventions assigned to this group

Catheter-based renal denervation

Renal denervation will be performed in the native renal arteries of patients after renal transplantation. Access side is the contralateral femoral artery.

Group Type EXPERIMENTAL

Catheter-based renal denervation

Intervention Type DEVICE

Interventions

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Catheter-based renal denervation

Intervention Type DEVICE

Other Intervention Names

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Renal denervation with Symplicity Catheter Medtronic/Ardian

Eligibility Criteria

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Inclusion Criteria

* Patient after renal transplantation (\> 6 month) without resection of native kidneys
* systolic blood pressure \>=150 mmHg
* on 3 or more antihypertensive medications
* Individual is 18 years of age
* Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.

Exclusion Criteria

* secondary causes and a white coat hypertension
* renal artery abnormalities
* eGFR \< 30mL/min (MDRD)
* angina
* severe Aortic valve stenosis
* Individual is pregnant, nursing or planning to be pregnant
* other
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Simon Schneider

Simon Schneider, MD; 1.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Unversität München

Locations

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1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München

Munich, , Germany

Site Status

Countries

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Germany

References

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Schneider S, Promny D, Sinnecker D, Byrne RA, Muller A, Dommasch M, Wildenauer A, Schmidt G, Heemann U, Laugwitz KL, Baumann M. Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve). Nephrol Dial Transplant. 2015 Nov;30(11):1928-36. doi: 10.1093/ndt/gfv311. Epub 2015 Sep 1.

Reference Type RESULT
PMID: 26333545 (View on PubMed)

Other Identifiers

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5548/12

Identifier Type: -

Identifier Source: org_study_id

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