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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01899456

Acronym

ISAR-denerve

Enrollment

Registered

2013-07-15

Start date

2013-07-31

Completion date

2015-11-30

Last updated

2015-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Hypertension, Renal Transplantation, Sympathetic Activity

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.

Interventions

DEVICECatheter-based renal denervation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026