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Completed

NCT Number: NCT01834118

Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension

The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CardioVascular Center Frankfurt

Frankfurt am Main, Hesse, 60389, Germany

About this study

Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.

In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.

For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.

There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individual is ≥18 years old
  • Individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.
  • Systolic Office based blood pressure ≥140mmHg
  • Individual receives 3 or more antihypertensive drugs including one diuretic
  • Individual is willing to provide written informed consent to participate in this study

Exclusion criteria

  • Individual has hypertension secondary to an identifiable and treatable cause
  • Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.
  • Individual is pregnant, nursing or planning to be pregnant
  • Renal artery abnormalities which may affect the procedure

Treatment and study plan

Renal Denervation

Procedure

Sympathetic nerve ablation via transcatheter renal denervation

Other names: Renal sympathetic nerve ablation

Primary outcomes

  1. Office Blood pressure measurement

    Time frame: up to1 year

Sponsors and collaborators

Lead sponsor

Cardiovascular Center Frankfurt

Other

Registry information

Official study title

Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension

Acronym: RETREAT

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2013
Registry last updated
Jul 28, 2016

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.

Published trials that share one or more normalized conditions with this study.