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

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.

Clinical Trials on Therapy Resistant Arterial Hypertension

Clinical Trials on Renal sympathetic denervation (RDN)

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