Clinical trial NCT02772939: Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
Official title: Evaluation of Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapy Resistant Arterial Hypertension
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation
timeFrame: 3 Months
measure: 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
timeFrame: 3 Months
Secondary outcomes:
measure: Change in 24h ambulatory blood pressure
timeFrame: 3 months, 6 months, 12 months
measure: Change in exercise blood pressure
timeFrame: 3 months
measure: Predictive value of MRI-assessed aortic distensibility on Change in daytime ambulatory blood pressure
timeFrame: 3 months, 6 months, 12 months
measure: Predictive value of MRI-assessed aortic distensibility on Change in 24 h ambulatory blood pressure
timeFrame: 3 months, 6 months, 12 months
measure: Predictive value of MRI-assessed total arterial compliance on Change in daytime ambulatory blood pressure
timeFrame: 3 months, 6 months, 12 months
measure: Predictive value of MRI-assessed total arterial compliance on Change in 24 h ambulatory blood pressure
timeFrame: 3 months, 6 months, 12 months
measure: 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
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center of the University Leipzig
Study officials:
References: