Blood pressure and LDL-cholesterol targets for prevention of recurrent strokes and cognitive decline in the hypertensive patient: design of the European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment randomize

Zanchetti A, Liu L, Mancia G, Parati G, Grassi G, Stramba-Badiale M, Silani V, Bilo G, Corrao G, Zambon A, Scotti L, Zhang X, Wang H, Zhang Y, Zhang X, Guan TR, Berge E, Redon J, Narkiewicz K, Dominiczak A, Nilsson P, Viigimaa M, Laurent S, Agabiti-Rosei E, Wu Z, Zhu D, Luis Rodicio J, Miguel Ruilope L, Martell-Claros N, Pinto F, Schmieder R, Burnier M, Banach M, Cifkova R, Farsang C, Konradi A, Lazareva I, Sirenko Y, Dorobantu M, Postadzhiyan A, Accetto R, Jelakovic B, Lovic D, Manolis AJ, Stylianou P, Erdine S, Dicker D, Wei G, Xu C, Xie H, Coca A, O'Brien J, Ford G (2014)

Publication Type: Journal article

Publication year: 2014

Journal

Book Volume: 32

Pages Range: 1888-97

Journal Issue: 9

DOI: 10.1097/HJH.0000000000000254

Abstract

The SBP values to be achieved by antihypertensive therapy in order to maximize reduction of cardiovascular outcomes are unknown; neither is it clear whether in patients with a previous cardiovascular event, the optimal values are lower than in the low-to-moderate risk hypertensive patients, or a more cautious blood pressure (BP) reduction should be obtained. Because of the uncertainty whether 'the lower the better' or the 'J-curve' hypothesis is correct, the European Society of Hypertension and the Chinese Hypertension League have promoted a randomized trial comparing antihypertensive treatment strategies aiming at three different SBP targets in hypertensive patients with a recent stroke or transient ischaemic attack. As the optimal level of low-density lipoprotein cholesterol (LDL-C) level is also unknown in these patients, LDL-C-lowering has been included in the design.The European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment trial is a prospective multinational, randomized trial with a 3 × 2 factorial design comparing: three different SBP targets (1, <145-135; 2, <135-125; 3, <125 mmHg); two different LDL-C targets (target A, 2.8-1.8; target B, <1.8 mmol/l). The trial is to be conducted on 7500 patients aged at least 65 years (2500 in Europe, 5000 in China) with hypertension and a stroke or transient ischaemic attack 1-6 months before randomization. Antihypertensive and statin treatments will be initiated or modified using suitable registered agents chosen by the investigators, in order to maintain patients within the randomized SBP and LDL-C windows. All patients will be followed up every 3 months for BP and every 6 months for LDL-C. Ambulatory BP will be measured yearly.Primary outcome is time to stroke (fatal and non-fatal). Important secondary outcomes are: time to first major cardiovascular event; cognitive decline (Montreal Cognitive Assessment) and dementia. All major outcomes will be adjudicated by committees blind to randomized allocation. A Data and Safety Monitoring Board has open access to data and can recommend trial interruption for safety.It has been calculated that 925 patients would reach the primary outcome after a mean 4-year follow-up, and this should provide at least 80% power to detect a 25% stroke difference between SBP targets and a 20% difference between LDL-C targets.

Authors with CRIS profile

Involved external institutions

University Hospital St. Anna Bulgaria (BG) Ljubljana University Medical Centre (Ljubljana UMC) / Univerzitetni klinični center Ljubljana Slovenia (SI) Zagreb University Hospital Centre / Klinički bolnički centar Zagreb (KBC) Croatia (HR) Asclepeion Hospital Greece (GR) Nicosia General Hospital Cyprus (CY) Istanbul University / İstanbul Üniversitesi Turkey (TR) Rabin Medical Center / מרכז רפואי רבין‎‎ Israel (IL) Beijing Xuanwu Hospital China (CN) Peking University (PKU) / 北京大学 China (CN) Universitat de Barcelona (UB) / University of Barcelona Spain (ES) University of Cambridge United Kingdom (GB) Oxford University Hospitals NHS Foundation Trust United Kingdom (GB) Istituto Scientifico Ospedale San Luca (Istituto Auxologico Italiano) Italy (IT) Fuwai Cardiovascular Hospital China (CN) University of Milano-Bicocca / Università degli Studi di Milano-Bicocca, UNIMIB Italy (IT) Chinese Hypertension League China (CN) Oslo University Hospital / Oslo Universitetssykehus Rikshospitalet Norway (NO) Medical University Gdansk / Gdański Uniwersytet Medyczny Poland (PL) University of Glasgow United Kingdom (GB) Lund University / Lunds universitet Sweden (SE) Tallinn University of Technology Estonia (EE) Georges Pompidou European Hospital / Hôpital Européen Georges-Pompidou (HEGP) France (FR) Università degli Studi di Brescia Italy (IT) Beijing Anzhen Hospital China (CN) Universidad Complutense de Madrid (UCM) Spain (ES) Hospital Universitario 12 de Octubre Spain (ES) Hospital Clínico San Carlos Spain (ES) Centro Hospitalar de Entre o Douro e Vouga, E.P.E. Portugal (PT) Lausanne University Hospital / Centre hospitalier universitaire vaudois (CHUV) Switzerland (CH) Medical University of Łódź / Uniwersytet Medyczny w Łodzi Poland (PL) University of València / Universitat de València Spain (ES) St. Imre Teaching Hospital Hungary (HU) Federal Almazov North-West Medical Research Centre Russian Federation (RU) Respublican Scientific and Practical Center “Cardiology” Belarus (BY) M.D. Strazhesko Institute of Cardiology Ukraine (UA) Bucharest Emergency University Hospital Romania (RO) Univerzita Karlova v Praze / Charles University in Prague Czech Republic (CZ)

How to cite

APA:

Zanchetti, A., Liu, L., Mancia, G., Parati, G., Grassi, G., Stramba-Badiale, M.,... Ford, G. (2014). Blood pressure and LDL-cholesterol targets for prevention of recurrent strokes and cognitive decline in the hypertensive patient: design of the European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment randomize. Journal of Hypertension, 32(9), 1888-97. https://doi.org/10.1097/HJH.0000000000000254

MLA:

Zanchetti, Alberto, et al. "Blood pressure and LDL-cholesterol targets for prevention of recurrent strokes and cognitive decline in the hypertensive patient: design of the European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment randomize." Journal of Hypertension 32.9 (2014): 1888-97.

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