Rationale and study design of the prospective comparison of angiotensin receptor neprilysin inhibitor with angiotensin receptor blocker measuring arterial stiffness in the elderly (PARAMETER) study

BMJ Open

Volumn 4, Issue 2, 2014, Pages

  Williams, Bryan ^a   Cockcroft, John R ^b   Kario, Kazuomi ^c   Zappe, Dion H ^d   Cardenas, Pamela ^d   Hester, Allen ^d   Brunel, Patrick ^d   Zhang, Jack ^d  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b CARDIFF UNIVERSITY   (United Kingdom)

^c JICHI MEDICAL UNIVERSITY   (Japan)

^d NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

3 (1 BIPHENYL 4 YLMETHYL 3 ETHOXYCARBONYL 1 BUTYLCARBAMOYL)PROPIONIC ACID PLUS VALSARTAN; AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN; AMINOBUTYRIC ACID DERIVATIVE; ANGIOTENSIN 1 RECEPTOR ANTAGONIST; IMIDAZOLE DERIVATIVE; MEMBRANE METALLOENDOPEPTIDASE; SACUBITRIL PLUS VALSARTAN; TETRAZOLE DERIVATIVE;

ADD ON THERAPY; ADULT; AORTA PRESSURE; ARTERIAL STIFFNESS; ARTICLE; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; HUMAN; MAJOR CLINICAL STUDY; MIDDLE AGED; MONOTHERAPY; MULTICENTER STUDY; PROSPECTIVE STUDY; PULSE PRESSURE; RANDOMIZED CONTROLLED TRIAL; SYSTOLIC BLOOD PRESSURE; SYSTOLIC HYPERTENSION; AGED; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; DRUG EFFECTS; DRUG MONITORING; FEMALE; HEMODYNAMICS; HYPERTENSION; MALE; METHODOLOGY; TREATMENT OUTCOME;

AGED; AMINOBUTYRATES; ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; DOUBLE-BLIND METHOD; DRUG MONITORING; FEMALE; HEMODYNAMICS; HUMANS; HYPERTENSION; IMIDAZOLES; MALE; MIDDLE AGED; NEPRILYSIN; PROSPECTIVE STUDIES; RESEARCH DESIGN; TETRAZOLES; TREATMENT OUTCOME; VASCULAR STIFFNESS;

EID: 84896885011     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2013-004254     Document Type: Article

References (46)

1. Kearney PM, Whelton M, Reynolds K, et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005;365:217-23. (Pubitemid 40138015)
2. Lawes CM, Vander HS, Rodgers A. Global burden of blood-pressure-related disease, 2001. Lancet 2008;371:1513-18. (Pubitemid 351626187)
3. Lionakis N, Mendrinos D, Sanidas E, et al. Hypertension in the elderly. World J Cardiol 2012;4:135-47.
4. Arguedas JA, Perez MI, Wright JM. Treatment blood pressure targets for hypertension. Cochrane Database Syst Rev 2009;(3): CD004349.
5. Franklin SS, Jacobs MJ, Wong ND, et al. Predominance of isolated systolic hypertension among middle-aged and elderly US hypertensives: analysis based on National Health and Nutrition Examination Survey (NHANES) III. Hypertension 2001;37:869-74. (Pubitemid 32221606)
6. Vasan RS, Beiser A, Seshadri S, et al. Residual lifetime risk for developing hypertension in middle-aged women and men: the Framingham Heart Study. JAMA 2002;287:1003-10. (Pubitemid 34252058)
7. Palatini P, Casiglia E, Gasowski J, et al. Arterial stiffness, central hemodynamics, and cardiovascular risk in hypertension. Vasc Health Risk Manag 2011;7:725-39.
8. Vlachopoulos C, Aznaouridis K, O'Rourke MF, et al. Prediction of cardiovascular events and all-cause mortality with central haemodynamics: a systematic review and meta-analysis. Eur Heart J 2010;31:1865-71.
9. Mitchell GF, Vasan RS, Keyes MJ, et al. Pulse pressure and risk of new-onset atrial fibrillation. JAMA 2007;297:709-15. (Pubitemid 46294560)
10. Waldstein SR, Rice SC, Thayer JF, et al. Pulse pressure and pulse wave velocity are related to cognitive decline in the Baltimore Longitudinal Study of Aging. Hypertension 2008;51:99-104. (Pubitemid 350307110)
11. Ford ML, Tomlinson LA, Chapman TP, et al. Aortic stiffness is independently associated with rate of renal function decline in chronic kidney disease stages 3 and 4. Hypertension 2010;55:1110-15.
12. Manisty CH, Hughes AD. Meta-analysis of the comparative effects of different classes of antihypertensive agents on brachial and central systolic blood pressure, and augmentation index. Br J Clin Pharmacol 2013;75:79-92.
13. Roman MJ, Devereux RB, Kizer JR, et al. Central pressure more strongly relates to vascular disease and outcome than does brachial pressure: the Strong Heart Study. Hypertension 2007;50:197-203. (Pubitemid 46986041)
14. Roman MJ, Okin PM, Kizer JR, et al. Relations of central and brachial blood pressure to left ventricular hypertrophy and geometry: the Strong Heart Study. J Hypertens 2010;28:384-8.
15. Wang KL, Cheng HM, Chuang SY, et al. Central or peripheral systolic or pulse pressure: which best relates to target organs and future mortality? J Hypertens 2009;27:461-7.
16. Jankowski P, Kawecka-Jaszcz K, Czarnecka D, et al. Ascending aortic, but not brachial blood pressure-derived indices are related to coronary atherosclerosis. Atherosclerosis 2004;176:151-5. (Pubitemid 39078658)
17. Ostergren J, Poulter NR, Sever PS, et al. The Anglo-Scandinavian Cardiac Outcomes Trial: blood pressure-lowering limb: effects in patients with type II diabetes. J Hypertens 2008;26:2103-11.
18. Williams B, Lacy PS, Thom SM, et al. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation 2006;113:1213-25.
19. Mitchell GF, Izzo JL Jr, Lacourciere Y, et al. Omapatrilat reduces pulse pressure and proximal aortic stiffness in patients with systolic hypertension: results of the conduit hemodynamics of omapatrilat international research study. Circulation 2002;105:2955-61. (Pubitemid 34693826)
20. Veelken R, Schmieder RE. Neutral endopeptidase inhibition: the potential of a new therapeutic approach in cardiovascular disease evolves. J Hypertens 2002;20:599-603. (Pubitemid 34913698)
21. Ruilope LM, Dukat A, Bohm M, et al. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. Lancet 2010;375:1255-66.
22. Solomon SD, Zile M, Pieske B, et al. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet 2012;380:1387-95.
23. Gallagher D, Adji A, O' Rourke MF. Validation of the transfer function technique for generating central from peripheral upper limb pressure waveform. Am J Hypertens 2004;17:1059-67. (Pubitemid 39469331)
24. Butlin M, Qasem A, Avolio AP. Estimation of central aortic pressure waveform features derived from the brachial cuff volume displacement waveform. Conf Proc IEEE Eng Med Biol Soc 2012;2012:2591-4.
25. Franssen PM, Imholz BP. Evaluation of the Mobil-O-Graph new generation ABPM device using the ESH criteria. Blood Press Monit 2010;15:229-31.
26. Jones CR, Taylor K, Chowienczyk P, et al. A validation of the Mobil O Graph (version 12) ambulatory blood pressure monitor. Blood Press Monit 2000;5:233-8.
27. Wei W, Tolle M, Zidek W, et al. Validation of the mobil-O-Graph: 24 h-blood pressure measurement device. Blood Press Monit 2010;15:225-8.
28. Westhoff TH, Straub-Hohenbleicher H, Schmidt S, et al. Convenience of ambulatory blood pressure monitoring: comparison of different devices. Blood Press Monit 2005;10:239-42. (Pubitemid 41502880)
29. Wassertheurer S, Mayer C, Breitenecker F. Modeling arterial and left ventricular coupling for non-invasive measurements. Simulation Model Pract Theory 2008;16:988-97.
30. Wassertheurer S, Kropf J, Weber T, et al. A new oscillometric method for pulse wave analysis: comparison with a common tonometric method. J Hum Hypertens 2010;24:498-504.
31. Nunan D, Wassertheurer S, Lasserson D, et al. Assessment of central haemomodynamics from a brachial cuff in a community setting. BMC Cardiovasc Disord 2012;12:48.
32. Weber T, Wassertheurer S, Rammer M, et al. Validation of a brachial cuff-based method for estimating central systolic blood pressure. Hypertension 2011;58:825-32.
33. Weiss W, Gohlisch C, Harsch-Gladisch C, et al. Oscillometric estimation of central blood pressure: validation of the Mobil-O-Graph in comparison with the SphygmoCor device. Blood Press Monit 2012;17:128-31.
34. Hametner B, Wassertheurer S, Kropf J, et al. Wave reflection quantification based on pressure waveforms alone - methods, comparison, and clinical covariates. Comput Methods Programs Biomed 2013;109:250-9.
35. Hametner B, Wassertheurer S, Kropf J, et al. Oscillometric estimation of aortic pulse wave velocity: comparison with intra-aortic catheter measurements. Blood Press Monit 2013;18:173-6.
36. Luzardo L, Lujambio I, Sottolano M, et al. 24-h ambulatory recording of aortic pulse wave velocity and central systolic augmentation: a feasibility study. Hypertens Res 2012;35:980-7.
37. Reppel M, Franzen K, Bode F, et al. Central hemodynamics and arterial stiffness during the finals of the world cup soccer championship 2010. Int J Cardiol 2013;166:627-32.
38. Weber T, Wassertheurer S, Rammer M, et al. Wave reflections, assessed with a novel method for pulse wave separation, are associated with end-organ damage and clinical outcomes. Hypertension 2012;60:534-41.
39. Weber T, Wassertheurer S, O' Rourke MF, et al. Pulsatile hemodynamics in patients with exertional dyspnea: potentially of value in the diagnostic evaluation of suspected heart failure with preserved ejection fraction. J Am Coll Cardiol 2013;61:1874-83.
40. Protogerou AD, Argyris A, Nasothimiou E, et al . Feasibility and reproducibility of noninvasive 24-h ambulatory aortic blood pressure monitoring with a brachial cuff-based oscillometric device. Am J Hypertens 2012;25:876-82.
41. Levin ER, Gardner DG, Samson WK. Natriuretic peptides. N Engl J Med 1998;339:321-8. (Pubitemid 28366422)
42. London GM, Weiss YA, Pannier BP, et al. Tilt test in essential hypertension. Differential responses in heart rate and vascular resistance. Hypertension 1987;10:29-34. (Pubitemid 17104009)
43. Okada Y, Galbreath MM, Shibata S, et al. Morning blood pressure surge is associated with arterial stiffness and sympathetic baroreflex sensitivity in hypertensive seniors. Am J Physiol Heart Circ Physiol 2013;305:H793-802.
44. Booysen HL, Norton GR, Maseko MJ, et al. Aortic, but not brachial blood pressure category enhances the ability to identify target organ changes in normotensives. J Hypertens 2013;31:1124-30.
45. Chazova IE, Dongre N, Vigdorchik AV. Real-life safety and effectiveness of amlodipine/valsartan combination in the treatment of hypertension. Adv Ther 2011;28:134-49.
46. Palmer BF. Improving BP control with combined renin-angiotensin system blockade and thiazide diuretics in hypertensive patients with diabetes mellitus or kidney disease. Am J Cardiovasc Drugs 2008;8:9-14. (Pubitemid 351311515)