- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02772939
Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation (EFFECTIVENES)
August 9, 2022 updated by: Philipp Lurz, Heart Center Leipzig - University Hospital
Evaluation of Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
This trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leipzig, Germany, 04289
- Heart Center of the University Leipzig
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Renal Denervation
Renal denervation for therapy resistant arterial hypertension
|
Catheter based renal sympathetic denervation for therapy resistant arterial hypertension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 Months
|
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
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in 24h ambulatory blood pressure
Time Frame: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
Change in exercise blood pressure
Time Frame: 3 months
|
3 months
|
Predictive value of MRI-assessed aortic distensibility on Change in daytime ambulatory blood pressure
Time Frame: 3 months, 6 months, 12 months
|
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
|
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
|
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
|
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
|
3 months, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
March 10, 2016
First Submitted That Met QC Criteria
May 11, 2016
First Posted (Estimate)
May 16, 2016
Study Record Updates
Last Update Posted (Actual)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Effectiveness0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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