Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension

N/ACompletedNCT02920034

Heart Center Leipzig - University Hospital120 enrolled

Overview

Prospective, randomized trial to assess the effectiveness of different renal sympathetic denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a cohort of patients with therapy refractory arterial hypertension and large renal arteries

The aim of this trial is a prospective, randomized comparison of three different techniques for catheter based renal sympathetic denervation. Patients with larger (\>5.5 mm) renal arteries are randomized to a treatment with a radiofrequency based catheter of the main renal artery, the main renal artery, its side-branches and accessories or an ultrasound-based denervation of the main renal artery only. The primary endpoint is the change in daytime blood pressure acquired in ambulatory blood pressure measurement at 3 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Therapy Resistant Hypertension

Interventions

Radiofrequency denervation of the main renal arteriesDEVICE

Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA)

Radiofrequency denervation of renal arteries and branchesDEVICE

Catheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA)

Ultrasound denervation of the main renal arteriesDEVICE

Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with resistant hypertension (≥3 antihypertensive drugs including at least one diuretic, without any dosage change in the preceding 4 weeks) and a systolic office blood pressure of \>160 mmHg, ≥1 main renal artery diameter \>5.5 mm Exclusion Criteria: * pregnancy, known renal artery stenosis, average systolic daytime RR \<135 mmHg in 24h ambulatory blood pressure measurement (ABPM), ≥1 renal artery diameter \<4.0 mm, life-expectancy \<6 months, participation in any other clinical trial.

Locations (1)

Heart Center of the University Leipzig

Leipzig, Germany

Outcomes

Primary Outcomes

Daytime blood pressure change

Daytime blood pressure change in ambulatory blood pressure measurement

Time frame: 3 months after Intervention

Secondary Outcomes

General blood pressure change

Change in 24 h average blood pressure change in ambulatory blood pressure measurement

Time frame: 3 months after Intervention

Daytime blood pressure change

Daytime blood pressure change in ambulatory blood pressure measurement

Time frame: 6 months after Intervention

General blood pressure change

Change in 24 h average blood pressure change in ambulatory blood pressure measurement

Time frame: 6 months after Intervention

Daytime blood pressure change

Daytime blood pressure change in ambulatory blood pressure measurement

Time frame: 12 months after Intervention

Daytime blood pressure change

Daytime blood pressure change in ambulatory blood pressure measurement

Time frame: 24 months after Intervention

General blood pressure change

Change in 24 h average blood pressure change in ambulatory blood pressure measurement

Time frame: 12 months after Intervention

General blood pressure change

Change in 24 h average blood pressure change in ambulatory blood pressure measurement

Data from ClinicalTrials.gov

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