• Cardiology Clinical Trials
• Hypertensive Disease

• Cardiology Clinical Trials
• Hypertensive Disease
• Cardiology

The findings of the multicenter Better Control of Blood Pressure in Hypertensive Patients Monitored Using the HOTMAN System trial [BEAUTY; NCT01482364] of 153 patients has shown the value of the simple and noninvasive monitoring of hemodynamic parameters in improving uncontrolled hypertension. The findings were reported by Tommaso Comotti, MD, Istituto Auxologico Italiano, Milan, Italy.

High blood pressure (BP) remains uncontrolled in up to 20% of those treated for hypertension [de la Sierra A et al. Hypertension 2011; Egan BM et al. Circulation 2011]. The ultimate control of drug-treated but still uncontrolled hypertension may require more or better-acting drugs [Redón J et al. J Hypertens 2010]. Poor adherence due to side effects is also a problem [Ceral J et al. Hypertens Res 2011; Gifford RW. Hypertension 1988; Klein LE. Hypertension 1988].

Another option for BP control is the use of an approach termed integrated hemodynamic management. The approach relies on the technique of thoracic electrical bioimpedance, which, by means of externally placed probes, measures the electrical resistance of the thorax to a high-frequency, very-low-magnitude current. The method permits real-time hemodynamic measurements, and the low current used reduces artifacts. The technology is commercially available as the HOTMAN system (Hemo Sapiens, San Ramon, CA, USA).

BEAUTY was a prospective randomized trial designed to explore whether drug selection based on integrated hemodynamic management would improve the hemodynamic status of patients with uncontrolled hypertension during a 6-month follow-up (n=76; patients also received usual hypertensive care; IHM Group), compared with drugs selected conventionally according to the 2007 European Society for Hypertension guidelines (n=77; control group). The primary end point of the study was the absolute change in daytime ambulatory systolic BP. Whether the drug-related changes in hemodynamic parameters are related to BP alterations and whether the improvements in hemodynamic and BP control reduced adverse effects were also assessed.

Hemodynamic status was assessed as worsened, stable, or improved based on comparison of values obtained at baseline and the final clinic visit. The 2 investigators were blind to patient randomization. Inclusion criteria were age 18 to 75 years, essential hypertension, sustained hypertension at the baseline visit (systolic BP >140 mm Hg) and during ambulatory BP monitoring (daytime systolic BP >135 mm Hg), treatment with ≥2 antihypertensive drugs, and signed informed consent. Patients were monitored during 6 clinic visits (ambulatory BP monitoring, echocardiography, HOTMAN, and pulse wave velocity; not all performed at each visit); they also maintained a BP diary.

Overall, hemodynamic status of the IHM group improved more (49% and 50%, according to both investigators) than did the control group (27% and 29%; p=0.038 and p=0.008, respectively). Joint improvement of hemodynamic status and BP was superior in the treatment group (42% and 43%) than in the control group (22% and 23%; p=0.014 and p=0.030, respectively). Drug selection according to the HOTMAN responses was associated with fewer investigator-assessed side effects (1.18±1.17) than was the conventional drug-selection process (1.91±2.09).

Data from BEAUTY suggest that the noninvasive HOTMAN approach is associated with more favorable hemodynamic changes in patients with uncontrolled hypertension, better joint control of hemodynamics and BP, and fewer side effects. Future studies are necessary to determine whether treatment strategies guided by integrated hemodynamic management will translate into improved clinical outcomes that are cost-effective.

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