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Completed

NCT Number: NCT01899456

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Renal Transplantation Sympathetic Activity Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Munich, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter-based renal denervation

Device

Other names: Renal denervation with Symplicity Catheter Medtronic/Ardian

Primary outcomes

  1. Safety and efficacy of renal denervation in patients after renal transplantation

    Time frame: 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 outcomes

  1. Effect of renal denervation in patients after renal transplantation on different organ systems.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: ISAR-denerve

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2013
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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