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

Technical University of Munich18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Chronic Kidney Disease Renal Transplantation Sympathetic Activity

Interventions

Catheter-based renal denervationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Munich, Germany

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 6 months

Secondary Outcomes

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).

Time frame: Baseline to 6 month

Data from ClinicalTrials.gov

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