Resistant hypertension optimal treatment trial: a randomized controlled trial

ReHOT Investigators, Eduardo M Krieger, Luciano F Drager, Dante Marcelo Artigas Giorgi, Jose Eduardo Krieger, Alexandre Costa Pereira, José Augusto Soares Barreto-Filho, Armando da Rocha Nogueira, José Geraldo Mill, Eduardo M Krieger, Luciano F Drager, Dante Marcelo Artigas Giorgi, Jose Eduardo Krieger, Alexandre Costa Pereira, Augusto Soares Barreto-Filho, Armando da Rocha Nogueira, Geraldo Mill, Alessandro Betito, Diogo Duarte Fagundes Moia, Paulo A Lotufo, Décio Mion Jr, Carlos Alberto Machado, Marcelo da Costa Batista, Antônio Carlos de Camargo Carvalho, Celso Amodeo, Fernando Nobre, Roberto Jorge da Silva Franco, Claudio Lucas da Nóbrega, Maria Eliane Campos Magalhães, Antônio Felipe Sanjuliani, Antônio Luiz Pinho Ribeiro, Raimundo Marques do Nascimento, Flávio Fuchs Danni, Iran Castro, Luís Carlos Bodanese, Armênio Costa Guimarães, Maria do Carmo Borges Teixeira, Gilson Soares Feitosa, Carlos Roberto Martins Rodrigues Sobrinho, Hilton Chaves, Eduardo Augusto da Silva Costa, Paulo César Brandão Veiga Jardim, ReHOT Investigators, Eduardo M Krieger, Luciano F Drager, Dante Marcelo Artigas Giorgi, Jose Eduardo Krieger, Alexandre Costa Pereira, José Augusto Soares Barreto-Filho, Armando da Rocha Nogueira, José Geraldo Mill, Eduardo M Krieger, Luciano F Drager, Dante Marcelo Artigas Giorgi, Jose Eduardo Krieger, Alexandre Costa Pereira, Augusto Soares Barreto-Filho, Armando da Rocha Nogueira, Geraldo Mill, Alessandro Betito, Diogo Duarte Fagundes Moia, Paulo A Lotufo, Décio Mion Jr, Carlos Alberto Machado, Marcelo da Costa Batista, Antônio Carlos de Camargo Carvalho, Celso Amodeo, Fernando Nobre, Roberto Jorge da Silva Franco, Claudio Lucas da Nóbrega, Maria Eliane Campos Magalhães, Antônio Felipe Sanjuliani, Antônio Luiz Pinho Ribeiro, Raimundo Marques do Nascimento, Flávio Fuchs Danni, Iran Castro, Luís Carlos Bodanese, Armênio Costa Guimarães, Maria do Carmo Borges Teixeira, Gilson Soares Feitosa, Carlos Roberto Martins Rodrigues Sobrinho, Hilton Chaves, Eduardo Augusto da Silva Costa, Paulo César Brandão Veiga Jardim

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.

© 2013 Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
Schematic view of the protocol. Laboratory includes hemogram, plasma Na and K, fasting glucose, urea, creatinine, total cholesterol, high‐density lipoprotein cholesterol, low‐density lipoprotein cholesterol, triglycerides, uric acid, summary of urine. Abbreviations: ABPM, ambulatory blood pressure monitoring; BP, blood pressure; EKG, electrocardiogram.
Figure 2
Figure 2
In step 1, 2000 patients with hypertension (220/130 ≥ BP ≥ 160/100 mm Hg) will be enrolled and titrated to the maximum dose of a 3‐drug combination therapy. Abbreviation: ReHy, resistant hypertension.

Source: PubMed

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