This trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Catheter based renal sympathetic denervation for therapy resistant arterial hypertension
Heart Center of the University Leipzig
Leipzig, Germany
Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation
difference in daytime blood pressure (ABPM) between patients with low (\<14.4 m/s) vs. high invasive pulse wave velocity
Time frame: 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
AUC of ROCs for noninvasive and invasive measures of arterial stiffness in predicting blood pressure response to renal denervation
Time frame: 3 Months
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
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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