Skip to main content
OpenTrials
Completed

NCT Number: NCT02772939

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Therapy Resistant Arterial Hypertension

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center of the University Leipzig

Leipzig, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal sympathetic denervation (RDN)

Device

Catheter based renal sympathetic denervation for therapy resistant arterial hypertension

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Heart Center Leipzig - University Hospital

Other

Registry information

Official study title

Evaluation of Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation

Acronym: EFFECTIVENES

Important dates

Study start
2015
Primary completion
2020
Study completion
2022
First posted
May 16, 2016
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.