Therapy Resistant Hypertension
Conditions
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.
Interventions
DEVICERadiofrequency denervation of the main renal arteries
Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA)
DEVICERadiofrequency denervation of renal arteries and branches
Catheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA)
DEVICEUltrasound denervation of the main renal arteries
Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA)
Sponsors
Heart Center Leipzig - University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daytime blood pressure change | 3 months after Intervention | Daytime blood pressure change in ambulatory blood pressure measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General blood pressure change | 3 months after Intervention | Change in 24 h average blood pressure change in ambulatory blood pressure measurement |
| Daytime blood pressure change | 6 months after Intervention | Daytime blood pressure change in ambulatory blood pressure measurement |
| Exercise blood pressure change | 3 months after Intervention | Change in exercise blood pressure on bicycle stress testing |
Countries
Germany
Outcome results
None listed