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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
  Purpose
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.

Condition Intervention
Hypertension, Resistant to Conventional Therapy Procedure: Renal Denervation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension

Further study details as provided by Prof. Dr. Horst Sievert, Cardiovascular Center Frankfurt:

Primary Outcome Measures:
  • Office Blood pressure measurement [ Time Frame: up to1 year ]

Enrollment: 10
Study Start Date: June 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Renal Denervation
    Sympathetic nerve ablation via transcatheter renal denervation
    Other Name: Renal sympathetic nerve ablation
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with treatment-resistant hypertension, who already underwent renal denervation with no therapeutic avail.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834118


Locations
Germany
CardioVascular Center Frankfurt
Frankfurt, Hessen, Germany, 60389
Sponsors and Collaborators
Cardiovascular Center Frankfurt
Investigators
Principal Investigator: Horst Sievert, M.D. Cardiovascular Center Frankfurt
  More Information

Responsible Party: Prof. Dr. Horst Sievert, M.D., Cardiovascular Center Frankfurt
ClinicalTrials.gov Identifier: NCT01834118     History of Changes
Other Study ID Numbers: CVC-001
First Submitted: April 15, 2013
First Posted: April 17, 2013
Last Update Posted: July 28, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Hypertension
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases