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

Technical University of Munich1 site in 1 country18 target enrollmentJuly 2013

ConditionsHypertension Chronic Kidney Disease Renal Transplantation Sympathetic Activity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: Technical University of Munich
Enrollment: 18
Locations: 1
Primary Endpoint: Safety and efficacy of renal denervation in patients after renal transplantation
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

November 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Technical University of Munich

Responsible Party

Principal Investigator

Simon Schneider

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

Technical University of Munich

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)
•severe Aortic valve stenosis
•Individual is pregnant, nursing or planning to be pregnant

Outcomes

Primary Outcomes

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.