Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study - a randomized controlled trial.
Both renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension. However, they have not been compared in a randomized clinical trial. We aimed to compare the efficacy of spironolactone versus RDN in patients with resistant hypertension.



A total of 24 patients with office SBP at least 150 mmHg and 24-h SBP at least 140 mmHg despite receiving at least three full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50 mg) as add-on therapy. Primary endpoint was change in 24-h SBP at 6 months. Comparisons between treatment groups were performed using generalized linear models adjusted by age, sex, and baseline values.



Spironolactone was more effective than RDN in reducing 24-h SBP and 24-h DBP: mean baseline-adjusted differences between the two groups were -17.9 mmHg (95%CI -30.9 to -4.9); P = 0.010 and -6.6 mmHg (95%CI -12.9 to -0.3); P = 0.041, for 24-h SBP and 24-h DBP, respectively. As regards changes in office blood pressure, mean baseline-adjusted differences between the two groups were -12.1 mmHg (95%CI -29.1 to 5.1); P = 0.158 and of -5.3 mmHg (95%CI -16.3 to 5.8); P = 0.332, for office SBP and office DBP, respectively. Otherwise, the decrease of estimated glomerular filtration rate was greater in the spironolactone group; mean baseline-adjusted difference between the two groups was -10.7 ml/min per 1.73 m (95%CI -20.1 to -1.4); P = 0.027.



We conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated' in all patients with resistant hypertension before considering RDN.
aHypertension Unit, Nephrology Department, Hospital Universitari del Mar, Barcelona IMIM (Hospital del Mar Medical Research Institute), Spanish Research Network REDINREN (RD12/0021/0024) bInternal Medicine Department, Vascular Risk Area, Hospital Moisés Broggi, Consorci Sanitari Integral cVascular Surgery Department, Hospital Universitari del Mar, Barcelona IMIM (Hospital del Mar Medical Research Institute) dInternal Medicine Department, Hospital Mútua Terrassa, University of Barcelona, Barcelona, Spain *Julio Pascual and Alejandro De la Sierra contributed equally to this work, and are the colast authors.
Anna
A
Oliveras
Pedro
P
Armario
Albert
A
Clarà
Laia
L
Sans-Atxer
Susana
S
Vázquez
Julio
J
Pascual
Alejandro
A
De la Sierra
D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory; D003329:Coronary Vasospasm / Q000188:drug therapy* / Q000601:surgery*; D004232:Diuretics / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000601:surgery*; D007668:Kidney / Q000294:innervation* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013148:Spironolactone / Q000627:therapeutic use*; D013562:Sympathectomy; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D004232:Diuretics; D013148:Spironolactone