Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation (ISAR-denerve)

Technical University of Munich

Status: Completed

Conditions: Chronic Kidney Disease; Hypertension; Sympathetic Activity; Renal Transplantation

Treatments: Device: Catheter-based renal denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT01899456

5548/12

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Medical therapy

No Intervention group

Description:

Best medical therapy using guideline recommended drugs in each disease state.

Catheter-based renal denervation

Experimental group

Description:

Renal denervation will be performed in the native renal arteries of patients after renal transplantation. Access side is the contralateral femoral artery.

Treatment:

Device: Catheter-based renal denervation