Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation

Not Applicable

Completed

• Conditions: Therapy Resistant Arterial Hypertension
• Interventions: Device: Renal sympathetic denervation (RDN)

• Registration Number: NCT02772939
• Lead Sponsor: Heart Center Leipzig - University Hospital

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-16
• Primary Completion: 2020-09
• Study Completion: 2022-05
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal sympathetic denervation (RDN)	Renal denervation for therapy resistant arterial hypertension

Primary Outcome Measures

Name	Time	Method
Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation	3 Months	difference in daytime blood pressure (ABPM) between patients with low (\<14.4 m/s) vs. high invasive pulse wave velocity
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	3 Months	AUC of ROCs for noninvasive and invasive measures of arterial stiffness in predicting blood pressure response to renal denervation

Secondary Outcome Measures

Name	Time	Method
Predictive value of MRI-assessed total arterial compliance on Change in daytime ambulatory blood pressure	3 months, 6 months, 12 months
Predictive value of MRI-assessed total arterial compliance on Change in 24 h ambulatory blood pressure	3 months, 6 months, 12 months
Change in 24h ambulatory blood pressure	3 months, 6 months, 12 months
Change in exercise blood pressure	3 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	3 months, 6 months, 12 months
Predictive value of MRI-assessed aortic distensibility on Change in daytime ambulatory blood pressure	3 months, 6 months, 12 months
Predictive value of MRI-assessed aortic distensibility on Change in 24 h ambulatory blood pressure	3 months, 6 months, 12 months

Trial Locations

Locations (1)

Heart Center of the University Leipzig; 🇩🇪 Leipzig, Germany