Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation

NCT ID: NCT02772939

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2022-05-31

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.

Conditions

Therapy Resistant Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal Denervation

Renal denervation for therapy resistant arterial hypertension

Group Type: EXPERIMENTAL

Renal sympathetic denervation (RDN)

Intervention Type: DEVICE

Catheter based renal sympathetic denervation for therapy resistant arterial hypertension

Interventions

Renal sympathetic denervation (RDN)

Catheter based renal sympathetic denervation for therapy resistant arterial hypertension

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Philipp Lurz

Clinical Investigator, Professor, Managing Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heart Center of the University Leipzig

Leipzig, , Germany

Countries

Germany

Other Identifiers

Effectiveness0001

Identifier Type: -

Identifier Source: org_study_id