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

Primary Purpose

Hypertension, Chronic Kidney Disease, Renal Transplantation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Catheter-based renal denervation
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Medical therapy

Catheter-based renal denervation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Safety and efficacy of renal denervation in patients after renal transplantation
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.

Secondary Outcome Measures

Effect of renal denervation in patients after renal transplantation on different organ systems.
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).

Full Information

First Posted
July 10, 2013
Last Updated
November 3, 2015
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01899456
Brief Title
Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation
Acronym
ISAR-denerve
Official Title
A Randomized Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation in Patients After Renal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Chronic Kidney Disease, Renal Transplantation, Sympathetic Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical therapy
Arm Type
No Intervention
Arm Description
Best medical therapy using guideline recommended drugs in each disease state.
Arm Title
Catheter-based renal denervation
Arm Type
Experimental
Arm Description
Renal denervation will be performed in the native renal arteries of patients after renal transplantation. Access side is the contralateral femoral artery.
Intervention Type
Device
Intervention Name(s)
Catheter-based renal denervation
Other Intervention Name(s)
Renal denervation with Symplicity Catheter Medtronic/Ardian
Primary Outcome Measure Information:
Title
Safety and efficacy of renal denervation in patients after renal transplantation
Description
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.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Effect of renal denervation in patients after renal transplantation on different organ systems.
Description
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).
Time Frame
Baseline to 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Schneider, MD
Organizational Affiliation
1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Unversität München
Official's Role
Principal Investigator
Facility Information:
Facility Name
1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26333545
Citation
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.
Results Reference
result

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

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