Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension

Completed

• Conditions: Hypertension, Resistant to Conventional Therapy

• Registration Number: NCT01834118
• Lead Sponsor: Cardiovascular Center Frankfurt

Brief Summary

The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.

Detailed Description

Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.

In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.

For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.

There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.

Study Timeline

• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-17
• Study Start: 2013-06
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Individual is ≥18 years old
• Individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.
• Systolic Office based blood pressure ≥140mmHg
• Individual receives 3 or more antihypertensive drugs including one diuretic
• Individual is willing to provide written informed consent to participate in this study

Exclusion Criteria

• Individual has hypertension secondary to an identifiable and treatable cause
• Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.
• Individual is pregnant, nursing or planning to be pregnant
• Renal artery abnormalities which may affect the procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Office Blood pressure measurement	up to1 year

Trial Locations

Locations (1)

CardioVascular Center Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany