A Randomized Comparison of Ultrasound Based Versus Radiofrequency Based Catheter Ablation Techniques in Patients With Therapy Resistant Arterial Hypertension With Large Renal Arteries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Therapy Resistant Hypertension
- Sponsor
- Heart Center Leipzig - University Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Daytime blood pressure change
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Philipp Lurz
Clinical Investigator, Professor, Managing Senior Physician
Heart Center Leipzig - University Hospital
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.
Outcomes
Primary Outcomes
Daytime blood pressure change
Time Frame: 3 months after Intervention
Daytime blood pressure change in ambulatory blood pressure measurement
Secondary Outcomes
- General blood pressure change(24 months after Intervention)
- Daytime blood pressure change(24 months after Intervention)
- Exercise blood pressure change(3 months after Intervention)