Fadl Elmula M Fadl Elmula1, Paola Rebora, Anneli Talvik, Sabrina Salerno, Eliza Miszkowska-Nagórna, Xiaoqiu Liu, Marika Heinpalu-Kuum, Tommaso Comotti, Anne C Larstorp, Morten Rostrup, Ewa Świerblewska, Maria Grazia Valsecchi, Sverre E Kjeldsen, Margus Viigimaa, Krzysztof Narkiewicz, Gianfranco Parati, Stéphane Laurent. 1. aSection for Cardiovascular and Renal Research, Ullevaal Hospital, Departments of Cardiology, Internal Medicine, Medical Biochemistry and Acute Medicine, and University of Oslo, Oslo Norway bDepartment of Health Sciences, University of Milan-Bicocca, Milan, Italy cNorth Estonia Medical Centre, Tallinn University of Technology, Tallinn, Estonia dDepartment of Cardiology S. Luca Hospital, Istituto Auxologico Italiano, IRCCS, Italy eDepartment of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland fDepartment of Pharmacology and INSERM U970 (SL), Hôpital Européen Georges Pompidou, Paris, France *Fadl Elmula M. Fadl Elmula, Paola Rebora, Anneli Talvik, Sabrina Salerno, Xiaoqiu Liu, and Marika Heinpalu-Kuum are joint first authors. †Maria Grazia Valsecchi, Sverre E. Kjeldsen, Margus Viigimaa, Krzysztof Narkiewicz, Gianfranco Parati, and Stéphane Laurent are joint senior authors.
Abstract
BACKGROUND: In the BEtter control of BP in hypertensive pAtients monitored Using the HOTMAN sYstem study, we investigated whether utilizing noninvasive monitoring of hemodynamic parameters combined with a drug selection algorithm (integrated hemodynamic management - IHM) compared with conventional drug selection may improve uncontrolled hypertension in European Hypertension Excellence centers. METHOD: Uncontrolled (office SBP >140 mmHg and ambulatory daytime SBP >135 mmHg while taking ≥2 antihypertensive drugs) essential hypertensive patients were referred to five European Hypertension Excellence centers and, if eligible, were randomized to IHM-guided (n = 83) vs. conventional (control, n = 84) treatment adjustment in an investigator-initiated multicenter prospective randomized parallel groups controlled study. RESULTS: The average number of antihypertensive drugs increased from 3.1 to 4.1 in both groups and differed only in a rise of the use of diuretics in the IHM groups (from 13 to 31%). Daytime SBP, defined as the primary endpoint, decreased markedly and to the same extent from baseline to 6 months in IHM (-15.8 ± 14.8 mmHg) and control (-15.4 ± 14.5 mmHg) groups (P = 0.87), with a similar behavior of office SBP (no between group differences, P = 0.18). Average number of adverse events was significantly lower in IHM than in controls (P = 0.008) but of the more general type and not necessarily related to drug treatment. CONCLUSION: Thus, noninvasive hemodynamic monitoring associated with a drug selection algorithm induced similar reductions in ambulatory daytime and office SBP compared with conventional drug selection in uncontrolled hypertensive patients referred to European Hypertension Excellence centers.Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT01482364.
RCT Entities:
BACKGROUND: In the BEtter control of BP in hypertensivepAtients monitored Using the HOTMAN sYstem study, we investigated whether utilizing noninvasive monitoring of hemodynamic parameters combined with a drug selection algorithm (integrated hemodynamic management - IHM) compared with conventional drug selection may improve uncontrolled hypertension in European Hypertension Excellence centers. METHOD: Uncontrolled (office SBP >140 mmHg and ambulatory daytime SBP >135 mmHg while taking ≥2 antihypertensive drugs) essential hypertensivepatients were referred to five European Hypertension Excellence centers and, if eligible, were randomized to IHM-guided (n = 83) vs. conventional (control, n = 84) treatment adjustment in an investigator-initiated multicenter prospective randomized parallel groups controlled study. RESULTS: The average number of antihypertensive drugs increased from 3.1 to 4.1 in both groups and differed only in a rise of the use of diuretics in the IHM groups (from 13 to 31%). Daytime SBP, defined as the primary endpoint, decreased markedly and to the same extent from baseline to 6 months in IHM (-15.8 ± 14.8 mmHg) and control (-15.4 ± 14.5 mmHg) groups (P = 0.87), with a similar behavior of office SBP (no between group differences, P = 0.18). Average number of adverse events was significantly lower in IHM than in controls (P = 0.008) but of the more general type and not necessarily related to drug treatment. CONCLUSION: Thus, noninvasive hemodynamic monitoring associated with a drug selection algorithm induced similar reductions in ambulatory daytime and office SBP compared with conventional drug selection in uncontrolled hypertensivepatients referred to European Hypertension Excellence centers.Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT01482364.
Authors: Jacob Volmer Stidsen; Jens Steen Nielsen; Jan Erik Henriksen; Søren Gunnar Friborg; Reimar Wernich Thomsen; Thomas Bastholm Olesen; Michael Hecht Olsen; Henning Beck-Nielsen Journal: BMJ Open Date: 2017-12-10 Impact factor: 2.692