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Randomized Controlled Trial

Resistant hypertension optimal treatment trial: a randomized controlled trial

ReHOT Investigators et al. Clin Cardiol. 2014 Jan.

Erratum in

  • Clin Cardiol. 2014 Jun;37(6):388. Multiple investigator names added

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.

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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.

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