A randomized and controlled study of noninvasive hemodynamic monitoring as a guide to drug treatment of uncontrolled hypertensive patients.
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.


METHODS
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.


CONCLUSIONS
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.
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.
Fadl Elmula M
FE
Fadl Elmula
Paola
P
Rebora
Anneli
A
Talvik
Sabrina
S
Salerno
Eliza
E
Miszkowska-Nagórna
Xiaoqiu
X
Liu
Marika
M
Heinpalu-Kuum
Tommaso
T
Comotti
Anne C
AC
Larstorp
Morten
M
Rostrup
Ewa
E
Świerblewska
Maria Grazia
MG
Valsecchi
Sverre E
SE
Kjeldsen
Margus
M
Viigimaa
Krzysztof
K
Narkiewicz
Gianfranco
G
Parati
Stéphane
S
Laurent
D000328:Adult; D000465:Algorithms; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure; D018660:Blood Pressure Monitoring, Ambulatory; D000066491:Clinical Decision-Making; D003661:Decision Support Techniques; D004232:Diuretics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D000959:Antihypertensive Agents; D004232:Diuretics