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Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation (EFFECTIVENES)

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ClinicalTrials.gov Identifier: NCT02772939
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Philipp Lurz, University of Leipzig

Tracking Information
First Submitted Date  ICMJE March 10, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date October 8, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
Predictive value of noninvasive and invasive measures of arterial stiffness (Pulse wave velocity and central pulse pressure assessed invasively, with a piezoelectric device and MRI-based) [ Time Frame: 3 Months ]
AUC of ROCs for noninvasive and invasive measures of arterial stiffness in predicting response to renal denervation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02772939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Change in 24h ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  • Change in exercise blood pressure [ Time Frame: 3 months ]
  • Predictive value of MRI-assessed aortic distensibility on Change in daytime ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  • Predictive value of MRI-assessed aortic distensibility on Change in 24 h ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  • Predictive value of MRI-assessed total arterial compliance on Change in daytime ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  • Predictive value of MRI-assessed total arterial compliance on Change in 24 h ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  • comparison of predictive value of invasive pulse wave velocity, invasive central pulse pressure, noninvasive pulse wave velocity, noninvasive central pulse pressure, aortic distensibility, total arterial compliance for Change in ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
Official Title  ICMJE Evaluation of Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
Brief Summary This trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation
Detailed Description Regardless of the ongoing debate on the general effect of renal sympathetic denervation in therapy resistant hypertension, all trials published so far face the problem of a certain proportion of nonresponders to treatment. Previous data shows, that to some extent this might be attributable to arterial stiffening. Elevated invasive pulse wave velocity as an established marker for arterial stiffness has been found to be associated with nonresponse to renal denervation treatment in a smaller trial population. This trial attempts to assess the predictive value of different invasive and non-invasive markers for arterial stiffness in an adequately powered population.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Therapy Resistant Arterial Hypertension
Intervention  ICMJE Device: Renal sympathetic denervation (RDN)
Catheter based renal sympathetic denervation for therapy resistant arterial hypertension
Study Arms  ICMJE Experimental: Renal Denervation
Renal denervation for therapy resistant arterial hypertension
Intervention: Device: Renal sympathetic denervation (RDN)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2017)
100
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
90
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with therapy resistant arterial hypertension (>=3 antihypertensive drugs including at least one diuretic without any dosage change in the preceding 4 weeks) and office BP >160 mmHg systolic or 90 mmHg diastolic

Exclusion Criteria:

  • average systolic daytime BP <135 mmHg in 24h ambulatory blood pressure measurement (ABPM)
  • pregnancy
  • known renal artery stenosis
  • >= 1 renal artery diameter < 4 mm
  • life expectancy <6 months
  • participation in any other clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772939
Other Study ID Numbers  ICMJE Effectiveness0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Philipp Lurz, University of Leipzig
Study Sponsor  ICMJE University of Leipzig
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Leipzig
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP