Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation (ISAR-denerve)

November 3, 2015 updated by: Simon Schneider, Technical University of Munich

A Randomized Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation in Patients After Renal Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81675
        • 1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Medical therapy
Best medical therapy using guideline recommended drugs in each disease state.
Experimental: 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.
Device: Catheter-based renal denervation
Other Names:
  • Renal denervation with Symplicity Catheter Medtronic/Ardian

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and efficacy of renal denervation in patients after renal transplantation
Time Frame: Baseline to 6 months
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events. Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of renal denervation in patients after renal transplantation on different organ systems.
Time Frame: Baseline to 6 month
Effects on sympathetic activity assessed by heart rate variability and post extrasystolic potentiation. Glucose metabolism and insulin resistance (fasting and during oGTT). Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).
Baseline to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Simon Schneider, MD, 1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Unversität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5548/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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