Targeted LOWering of Central Blood Pressure in patients with hypertension: Baseline recruitment,rationale and design of a randomized controlled trial (The LOW CBP study) |
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| Institution: | 1. Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia;2. Sunshine Coast University Hospital, Birtinya, Australia;3. School of Medicine, University of Queensland, Brisbane, Australia;4. Centre of Cardiovascular Research and Education in Therapeutics, Department of Epidemiology and Preventative Medicine, Monash University, Melbourne, Australia;5. School of Public Health, Curtin University, Perth, Australia;6. Sydney Medical School, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia;7. Royal Hobart Hospital, Department of Cardiology, Hobart, Australia;8. Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia;9. Australia National University, Canberra Hospital, Canberra, Australian Capital Territory, Australia;10. Endocrine Hypertension Research Centre, University of Queensland, School of Medicine, Princess Alexandra Hospital, Brisbane, Australia;1. Department of Biostatistics, Rutgers School of Public Health, Rutgers University, The State University of New Jersey, 683 Hoes Lane West, Piscataway, NJ 08854, USA;2. Division of Biometrics, Rutgers Cancer Institute of New Jersey, Rutgers University, The State University of New Jersey, 683 Hoes Lane West, Piscataway, NJ 08854, USA;1. Department of Electronic Engineering/Graduate School at Shenzhen, Tsinghua University, China;2. Shenzhen Key Laboratory of Information Science and Technology, Shenzhen, China;3. Department of Computer and Information Science, University of Macau, Macau, China |
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| Abstract: | BackgroundHigh blood pressure (BP) is the most common modifiable cause of death from cardiovascular disease. Lowering BP with medication improves patient outcomes, but even in populations with normal upper arm (brachial) BP there remains considerable residual risk for cardiovascular disease and this may be due to persistently elevated central BP. There has never been a trial to determine the value of targeted central BP lowering among patients with hypertension, and this was the aim of this study.MethodsThis is a multi-centre, randomized, open-label, blinded endpoint trial among 308 patients treated for uncomplicated hypertension with controlled brachial BP (< 140/90 mmHg) but elevated central BP (≥ 0.5SD above age- and sex-specific normal values). Baseline recruitment has been completed. Participants were randomized to intervention with spironolactone (25 mg/d) or usual care and are being followed over 24 months, with the primary outcome being left ventricular mass index (using cardiac magnetic resonance imaging). Brachial and central BP will be measured in the clinic, at home over 7-days and by 24-h ambulatory monitoring. Aortic stiffness will be assessed by carotid-to-femoral pulse wave velocity. Primary (intention to treat) analysis will determine the role of central versus brachial BP for predicting changes in left ventricular mass index.ConclusionsCompared with control, intervention is expected to significantly lower left ventricular mass index, and this effect is expected to be independently correlated with central BP lowering. These findings would support the concept of central BP as an important therapeutic target in hypertension management. Results are expected in 2018. |
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