Catheter-based renal denervation versus intensified medical treatment in patients with resistant hypertension: Rationale and design of a multicenter randomized study - PRAGUE-15
Abstract
Catheter-based renal denervation (RDN) was considered as a promising method for treatment of resistant hypertension and was increasingly being used worldwide. However, there are equivocal results from only two randomized trials studying the effect of such intervention.
Thus, additional data from properly designed long-term comparative trials are needed. The PRAGUE-15 trial is designed as an open, prospective, randomized multicenter trial comparing RDN versus intensified medical treatment in patients with resistant hypertension.
Patients randomized to the medical treatment group will receive spironolactone in the absence of contraindications. The primary endpoint will be changes in systolic and diastolic pressure during ambulatory blood pressure monitoring (ABPM) from baseline to 6 months.
Herein, we describe the trial design and methodology. The strengths of the trial include ABPM (as the objective endpoint), independent outcomes assessment, and therapeutic use of spironolactone.