Resistant Hypertension Optimal Treatment Trial: A Randomized Controlled Trial

Author(s)

Krieger, Eduardo M. ^[1] ; Drager, Luciano F. ^[1] ; Artigas Giorgi, Dante Marcelo ^[1] ; Krieger, Jose Eduardo ^[1] ; Pereira, Alexandre Costa ^[1] ; Soares Barreto-Filho, Jose Augusto ^[1] ; Nogueira, Armando da Rocha ^[1] ; Mill, Jose Geraldo ^[1] ; Investigators, ReHOT ^[2]

Affiliation

^[1] Sch Med, Heart Inst InCor, BR-05403900 Sao Paulo - Brazil

^[2] ReHOT Investigators, Univ Sao Paulo, Sch Med, Heart Inst InCor, BR-05403900 Sao Paulo - Brazil

• Document type: Journal article
• Source: CLINICAL CARDIOLOGY; v. 37, n. 1, p. 1-6, JAN 2014.
• Web of Science Citations: 17

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. (AU)

• FAPESP's process: 09/53282-8 - Multicenter trial of hypertensive patients for the identification of resistant hypertension and therapeutic standardization
• Grantee: Eduardo Moacyr Krieger
• Support Opportunities: Research Grants - Research in Public Policies for the National Health Care System (PP-SUS)