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

Hypertension Clinical Trial

— ISAR-denerve  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899456
• Other study ID #: 5548/12
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: November 3, 2015
• Start date: July 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic
• Renal Transplantation
• Sympathetic Activity

Intervention

Device:
• Catheter-based renal denervation

Locations

Country	Name	City	State
Germany	1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schneider S, Promny D, Sinnecker D, Byrne RA, Müller 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 Dia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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).	Baseline to 6 month	Yes