Clinical trial NCT02920034: Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension
Official title: A Randomized Comparison of Ultrasound Based Versus Radiofrequency Based Catheter Ablation Techniques in Patients With Therapy Resistant Arterial Hypertension With Large Renal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapy Resistant Hypertension
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Daytime blood pressure change
timeFrame: 3 months after Intervention
Secondary outcomes:
measure: General blood pressure change
timeFrame: 3 months after Intervention
measure: Daytime blood pressure change
timeFrame: 6 months after Intervention
measure: General blood pressure change
timeFrame: 6 months after Intervention
measure: Daytime blood pressure change
timeFrame: 12 months after Intervention
measure: Daytime blood pressure change
timeFrame: 24 months after Intervention
measure: General blood pressure change
timeFrame: 12 months after Intervention
measure: General blood pressure change
timeFrame: 24 months after Intervention
measure: Exercise blood pressure change
timeFrame: 3 months after Intervention
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center of the University Leipzig
Study officials:
affiliation: Heart Center of the University Leipzig
name: Philipp C Lurz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fengler K, Rommel KP, Lapusca R, Blazek S, Besler C, Hartung P, von Roeder M, Kresoja KP, Desch S, Thiele H, Lurz P. Renal Denervation in Isolated Systolic Hypertension Using Different Catheter Techniques and Technologies. Hypertension. 2019 Aug;74(2):341-348. doi: 10.1161/HYPERTENSIONAHA.119.13019. Epub 2019 Jun 17.
citation: Fengler K, Rommel KP, Blazek S, Besler C, Hartung P, von Roeder M, Petzold M, Winkler S, Hollriegel R, Desch S, Thiele H, Lurz P. A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN). Circulation. 2019 Jan 29;139(5):590-600. doi: 10.1161/CIRCULATIONAHA.118.037654.