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

Not Applicable

Completed

• Conditions: Hypertension; Chronic Kidney Disease; Sympathetic Activity; Renal Transplantation
• Interventions: Device: Catheter-based renal denervation

• Registration Number: NCT01899456
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Primary Completion: 2015-03
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter-based renal denervation	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.

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of renal denervation in patients after renal transplantation	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München; 🇩🇪 Munich, Germany