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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Cardiovascular Center Frankfurt
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Horst Sievert, Cardiovascular Center Frankfurt
ClinicalTrials.gov Identifier:
NCT01834118
First received: April 15, 2013
Last updated: July 11, 2014
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by Cardiovascular Center Frankfurt:

Primary Outcome Measures:
  • Office Blood pressure measurement [ Time Frame: up to1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834118

Contacts
Contact: Roger Eckhardt 0049 69 97947653 r.eckhardt@cvcfrankfurt.de

Locations
Germany
CardioVascular Center Frankfurt Recruiting
Frankfurt, Hessen, Germany, 60389
Contact: Roger Eckhardt    0049 69 97947653    r.eckhardt@cvcfrankfurt.de   
Principal Investigator: Horst Sievert, M.D.         
Sponsors and Collaborators
Cardiovascular Center Frankfurt
Investigators
Principal Investigator: Horst Sievert, M.D. Cardiovascular Center Frankfurt
  More Information

No publications provided

Responsible Party: Prof. Dr. Horst Sievert, M.D., Cardiovascular Center Frankfurt
ClinicalTrials.gov Identifier: NCT01834118     History of Changes
Other Study ID Numbers: CVC-001
Study First Received: April 15, 2013
Last Updated: July 11, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 20, 2014