title: Resistant hypertension optimal treatment trial: a randomized controlled trial.
abstract: The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, and calcium channel blockers are largely used as the first 3-drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin-angiotensin-aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study (ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3-month treatment with spironolactone (titrating dose, 12.5-50 mg once daily) or clonidine (titrating dose, 0.1-0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12-week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3-drug standard regimen.
authors: Eduardo M
authors: EM
authors: Krieger
authors: Luciano F
authors: LF
authors: Drager
authors: Dante Marcelo Artigas
authors: DM
authors: Giorgi
authors: Jose Eduardo
authors: JE
authors: Krieger
authors: Alexandre Costa
authors: AC
authors: Pereira
authors: José Augusto Soares
authors: JA
authors: Barreto-Filho
authors: Armando
authors: A
authors: da Rocha Nogueira
authors: José Geraldo
authors: JG
authors: Mill
mesh_terms: D058647:Adrenergic alpha-2 Receptor Agonists / Q000627:therapeutic use*; D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D001938:Brazil / Q000453:epidemiology; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D002985:Clinical Protocols; D003000:Clonidine / Q000627:therapeutic use*; D004232:Diuretics / Q000627:therapeutic use; D055808:Drug Discovery; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D015995:Prevalence; D012107:Research Design; D013148:Spironolactone / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004232:Diuretics; D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone; D003000:Clonidine