Changes In Subclinical Organ Damage In Patients With Resistant Hypertension Randomized To Receive Renal Denervation Or Spironolactone As Add-On Therapy. The Denervhta Study Results

Objective: Both renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension (RH). However, they have not been compared in a randomized clinical trial. We aimed to compare the effect of these two therapeutic strategies on subclinical target organ damage, in patients with RH. Design and method: Twenty-three patients with office systolic blood pressure (SBP) > = 150 mmHg and 24h-SBP > = 140 mmHg despite receiving > = 3 full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50 mg), as add-on therapy. Changes (δ) in 24h-BP, as well as changes in urinary albumin excretion (δUAE), carotid-femoral pulse-wave velocity (δcfPWV), intima-media thickness (δIMT) and echocardiographic left ventricular mass index (δLVMI) were evaluated at 6 months. Between-group comparisons of changes in UAE, cfPWV, IMT and LVMI were carried out by unpaired t-tests in normally distributed data or Mann-Whitney test in asymmetrically distributed data. Between-group comparison of δ24h-SBP was performed by using generalized linear model adjusted by age, gender and baseline 24h-SBP values. The associations of changes in subclinical target organ damage markers with δ24h-SBP were assessed with the Spearman correlation coefficients. Results: Mean baseline-adjusted difference (95% CI) between the two groups (Spironolactone vs.RDN) at 6 months in 24h-SBP (mmHg) was of −17.9 (−30.9 to −4.9), p = 0.01. There were no statistically significant differences between groups in changes in UAE, cfPWV, IMT and LVMI. In RDN and spironolactone groups, δUAE (mg/g) was of median [IQR] = −1.72 [−42,7; 16.9] and −14.9 [−81.2; −5,5], respectively, and δcfPWV (m/s) was of mean ± SD = −0.69 ± 1.66 and −1.34 ± 0.97, respectively. The correlation of δ24h-SBP with δUAE was 0.640 (p = 0.001) and the correlation of δ24h-SBP with δcfPWV was 0.560 (p = 0.007). There were no statistically significant correlacions of δ24h-SBP with δIMT or with δLVMI. Conclusions: As compared to RDN, spironolactone was more effective to reduce 24h-SBP after 6 months in patients with RH. Changes in subclinical target organ damage did not show differences between both groups of treatment. Globally, changes in UAE and in cfPWV significantly correlated with 24h-SBP variation at 6 months.