Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation (EFFECTIVENES)

Heart Center Leipzig - University Hospital

Status

Completed

Conditions

Therapy Resistant Arterial Hypertension

Treatments

Device: Renal sympathetic denervation (RDN)

Study type

Interventional

Funder types

Other

Identifiers

NCT02772939

Effectiveness0001

Details and patient eligibility

About

This trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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