NCT01899456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

July 10, 2013

Last Update Submit

November 3, 2015

Conditions

HypertensionChronic Kidney DiseaseRenal TransplantationSympathetic Activity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 6 months

Secondary Outcomes (1)

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

    Baseline to 6 month

Study Arms (2)

Medical therapy

NO INTERVENTION

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

Catheter-based renal denervation

EXPERIMENTAL

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

Interventions

Catheter-based renal denervationDEVICE
Also known as: Renal denervation with Symplicity Catheter Medtronic/Ardian
Catheter-based renal denervation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, 81675, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26333545RESULT

MeSH Terms

Conditions

HypertensionRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Simon Schneider, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Simon Schneider, MD; 1.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 15, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2015

Study Completion

November 1, 2015

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

DE(1)