[OP.4C.02] 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

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Abstract

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.

Objective:

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.

Design and method:

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.

Results:

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.

Results:

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.

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