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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 : Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Philipp Lurz, University of Leipzig

Study Description
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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

Condition or disease Intervention/treatment Phase
Therapy Resistant Arterial Hypertension Device: Renal sympathetic denervation (RDN) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
Study Start Date : June 2015
Actual Primary Completion Date : September 2020
Estimated Study Completion Date : May 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal Denervation
Renal denervation for therapy resistant arterial hypertension
 Device: Renal sympathetic denervation (RDN)
Catheter based renal sympathetic denervation for therapy resistant arterial hypertension


Outcome Measures
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Primary Outcome Measures :
  1. Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation [ Time Frame: 3 Months ]
    difference in daytime blood pressure (ABPM) between patients with low (<14.4 m/s) vs. high invasive pulse wave velocity

  2. Predictive value of noninvasive and invasive measures of arterial stiffness (Pulse wave velocity assessed invasively, with a piezoelectric device and MRI-based) in combination with clinical variables [ Time Frame: 3 Months ]
    AUC of ROCs for noninvasive and invasive measures of arterial stiffness in predicting blood pressure response to renal denervation


Secondary Outcome Measures :
  1. Change in 24h ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  2. Change in exercise blood pressure [ Time Frame: 3 months ]
  3. Predictive value of MRI-assessed aortic distensibility on Change in daytime ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  4. Predictive value of MRI-assessed aortic distensibility on Change in 24 h ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  5. Predictive value of MRI-assessed total arterial compliance on Change in daytime ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  6. Predictive value of MRI-assessed total arterial compliance on Change in 24 h ambulatory blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02772939


Locations
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Germany
Heart Center of the University Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
More Information
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Responsible Party: Philipp Lurz, Philipp Lurz, PhD, MD, University of Leipzig
ClinicalTrials.gov Identifier: NCT02772939    
Other Study ID Numbers: Effectiveness0001
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases