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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01834118
First Posted: April 17, 2013
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Dr. Horst Sievert, Cardiovascular Center Frankfurt
April 15, 2013
April 17, 2013
July 28, 2016
June 2013
April 2016   (Final data collection date for primary outcome measure)
Office Blood pressure measurement [ Time Frame: up to1 year ]
Same as current
Complete list of historical versions of study NCT01834118 on ClinicalTrials.gov Archive Site
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Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension
Reintervention 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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Year
Not Provided
Probability Sample
Patients with treatment-resistant hypertension, who already underwent renal denervation with no therapeutic avail.
Hypertension, Resistant to Conventional Therapy
Procedure: Renal Denervation
Sympathetic nerve ablation via transcatheter renal denervation
Other Name: Renal sympathetic nerve ablation
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Completed
10
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01834118
CVC-001
No
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Prof. Dr. Horst Sievert, Cardiovascular Center Frankfurt
Cardiovascular Center Frankfurt
Not Provided
Principal Investigator: Horst Sievert, M.D. Cardiovascular Center Frankfurt
Cardiovascular Center Frankfurt
July 2016