Favorable Effect of Renal Denervation on Stress and Anxiety Symptoms in Hypertensive Patients. Ersham Randomized Clinical Trial

Objective: Sympathetic nervous system overactivity contributes to both hypertension and anxiety. ERSHAM is the first randomized controlled trial (NCT05438446) to assess whether renal denervation not only lowers blood pressure but also improves anxiety and stress symptoms in patients with uncontrolled hypertension and anxiety. Design and method: Sixty patients with uncontrolled hypertension (office blood pressure between 140/90 and 160/100 mmHg) and anxiety subscore of hospital anxiety and depression scale (HADS-A) greater than or equal to eight were enrolled. Patients, drug-naïve or on monotherapy with a renin–angiotensin system inhibitor or calcium channel blocker, were randomized 1:1 to ultrasound renal denervation or control group (no intervention). Renal anatomy was confirmed by computed tomography angiography prior to randomization. Antihypertensive therapy was kept constant during the 3-month follow-up. Primary endpoint was change in anxiety subscore of hospital anxiety and depression scale at three months. Secondary endpoints were changes in 24-hour ambulatory blood pressure, Perceived Stress Scale-14 and mental component score of the 12-item Short Form Survey. Power analysis was performed based on a 1.7-point difference in HADS-A between groups (80% power, α =0.05). Results: Fifty-nine patients (mean age 54.9 years) completed follow-up (renal denervation group, n=29; control group, n=30). At three months, anxiety subscore decreased significantly after renal denervation (10.2 ± 2.9 to 4.5 ± 2.8; p<0.001) but remained unchanged in controls (p=0.77). Average 24-hour systolic/diastolic ambulatory BP decreased by 10.4 ± 12.9/6.2 ± 8.6 mmHg (both p<0.001) in the renal denervation group, with no significant change in controls. Similarly, perceived stress scale-14 improved markedly with renal denervation (p<0.001), while controls showed no meaningful change. Quality of life, reflected by mental component score of the short form survey, improved in the renal denervation group (p<0.001) with no significant variation in controls. Furthermore, analysis of covariance was performed for mean changes adjusting for baseline measurements. No procedure-related adverse events were reported. Conclusions: In patients with uncontrolled hypertension and anxiety symptoms, renal denervation significantly reduced blood pressure and improved anxiety, stress and mental well-being at three months. These findings highlight a potential beneficial modulatory role of renal denervation on neuropsychological and stress-related pathways.