Erratum: The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: The Systolic Blood Pressure Intervention Trial (SPRINT) (Clinical Trials (2014) 11:5 (532-546) DOI: 10.1177/1740774514537404);The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: The systolic blood pressure intervention trial (SPRINT)

Clinical Trials

Volumn 11, Issue 5, 2014, Pages 532-546

  Ambrosius, Walter T ^a   Sink, Kaycee M ^a   Foy, Capri G ^a   Berlowitz, Dan R ^b   Cheung, Alfred K ^b   Cushman, William C ^c   Fine, Lawrence J ^d   Goff, David C ^e   Johnson, Karen C ^f   Killeen, Anthony A ^g   Lewis, Cora E ^h   Oparil, Suzanne ⁱ   Reboussin, David M ^a   Rocco, Michael V ^a   Snyder, Joni K ^d   Williamson, Jeff D ^a   Wright, Jackson T ^j   Whelton, Paul K ^k  

^a WAKE FOREST SCHOOL OF MEDICINE   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c VETERANS AFFAIRS MEDICAL CENTER   (United States)

^d NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^e Global Health and Health Disparities   (United States)

^f UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^g UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^h University of Alabama at Birmingham   (United States)

ⁱ University of Alabama at Birmingham   (United States)

^j CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k TULANE UNIVERSITY   (United States)

more..

Author keywords

Blood pressure targets; Brain structure and function; Cardiovascular; Cognition; Geriatrics; Hypertension; Kidney; Major adverse cardiovascular outcomes; Randomized clinical trial; Stroke

Indexed keywords

ANTIHYPERTENSIVE AGENT; ANGIOTENSIN RECEPTOR ANTAGONIST; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; LOOP DIURETIC AGENT; THIAZIDE DIURETIC AGENT;

ACUTE CORONARY SYNDROME; AGED; BLOOD PRESSURE MEASUREMENT; BLOOD PRESSURE REGULATION; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; DEMENTIA; DIASTOLIC BLOOD PRESSURE; DRUG DOSE TITRATION; ELECTROCARDIOGRAM; END STAGE RENAL DISEASE; FEMALE; GLOMERULUS FILTRATION RATE; HEART FAILURE; HEART INFARCTION; HUMAN; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; MENTAL DETERIORATION; MULTICENTER STUDY (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; CARDIOVASCULAR DISEASE; CHRONIC KIDNEY FAILURE; CLINICAL PROTOCOL; CLINICAL TRIAL; COMPARATIVE STUDY; COMPLICATION; CONTROLLED STUDY; HYPERTENSION; MIDDLE AGED; MULTICENTER STUDY; PATIENT CARE PLANNING; RANDOMIZED CONTROLLED TRIAL; SYSTOLE; VERY ELDERLY;

ADRENERGIC BETA-ANTAGONISTS; AGED; AGED, 80 AND OVER; ANGIOTENSIN RECEPTOR ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; ANTIHYPERTENSIVE AGENTS; CALCIUM CHANNEL BLOCKERS; CARDIOVASCULAR DISEASES; CLINICAL PROTOCOLS; FEMALE; HUMANS; HYPERTENSION; MALE; MIDDLE AGED; PATIENT CARE PLANNING; RENAL INSUFFICIENCY, CHRONIC; SODIUM CHLORIDE SYMPORTER INHIBITORS; SODIUM POTASSIUM CHLORIDE SYMPORTER INHIBITORS; SYSTOLE; TREATMENT OUTCOME;

EID: 84908166637     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774517695238     Document Type: Erratum

References (71)

1. Kearney PM, Whelton M, Reynolds K, et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005; 365: 217-223.
2. 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: 869-874.
3. Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003; 289: 2560-2572.
4. Collins R, Peto R, MacMahon S, et al. Blood pressure, stroke, and coronary heart disease. Part 2, Short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context. Lancet 1990; 335: 827-838.
5. Gillum RF. Cardiovascular disease in the United States: an epidemiologic overview. Cardiovasc Clin 1991; 21: 3-16.
6. Hsu CY, McCulloch CE, Darbinian J, et al. Elevated blood pressure and risk of end-stage renal disease in subjects without baseline kidney disease. Arch Intern Med 2005; 165: 923-928.
7. Jackson R. Guidelines on preventing cardiovascular disease in clinical practice. BMJ 2000; 320: 659-661.
8. Levy D, Larson MG, Vasan RS, et al. The progression from hypertension to congestive heart failure. JAMA 1996; 275: 1557-1562.
9. MacMahon S, Peto R, Cutler J, et al. Blood pressure, stroke, and coronary heart disease. Part 1, prolonged differences in blood pressure: prospective observational studies corrected for the regression dilution bias. Lancet 1990; 335: 765-774.
10. Lewington S, Clarke R, Qizilbash N, et al.; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002; 360: 1903-1913.
11. Sacco RL, Boden-Albala B, Abel G, et al. Race-ethnic disparities in the impact of stroke risk factors: the northern Manhattan stroke study. Stroke 2001; 32: 1725-1731.
12. Staessen JA, Fagard R, Thijs L, et al. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. The Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Lancet 1997; 350: 757-764.
13. Vasan RS, Larson MG, Leip EP, et al. Impact of highnormal blood pressure on the risk of cardiovascular disease. N Engl J Med 2001; 345: 1291-1297.
14. Forette F, Seux ML, Staessen JA, et al. Prevention of dementia in randomised double-blind placebo-controlled Systolic Hypertension in Europe (Syst-Eur) trial. Lancet 1998; 352: 1347-1351.
15. Luchsinger JA and Mayeux R. Cardiovascular risk factors and Alzheimer's disease. Curr Atheroscler Rep 2004; 6: 261-266.
16. Reitz C, Tang MX, Manly J, et al. Hypertension and the risk of mild cognitive impairment. Arch Neurol 2007; 64: 1734-1740.
17. Skoog I and Gustafson D. Hypertension, hypertensionclustering factors and Alzheimer's disease. Neurol Res 2003; 25: 675-680.
18. Skoog I, Lithell H, Hansson L, et al. Effect of baseline cognitive function and antihypertensive treatment on cognitive and cardiovascular outcomes: study on COgnition and Prognosis in the Elderly (SCOPE). Am J Hypertens 2005; 18: 1052-1059.
19. Skoog I and Gustafson D. Update on hypertension and Alzheimer's disease. Neurol Res 2006; 28: 605-611.
20. Tzourio C, Anderson C, Chapman N, et al. Effects of blood pressure lowering with perindopril and indapamide therapy on dementia and cognitive decline in patients with cerebrovascular disease. Arch Intern Med 2003; 163: 1069-1075.
21. Lim S, Vos T, Flaxman A, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2224-2260.
22. Neal B, MacMahon S and Chapman N. Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials. Blood Pressure Lowering Treatment Trialists' Collaboration. Lancet 2000; 356: 1955-1964.
23. Psaty BM, Smith NL, Siscovick DS, et al. Health outcomes associated with antihypertensive therapies used as first-line agents. A systematic review and meta-analysis. JAMA 1997; 277: 739-745.
24. Beckett NS, Peters R, Fletcher AE, et al. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008; 358: 1887-1898.
25. Systolic Hypertension in the Elderly Program (SHEP). Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). SHEP Cooperative Research Group. JAMA 1991; 265: 3255-3264.
26. Cost effectiveness of intensive treatment of hypertension. Based on presentations by Donald S. Shepard, PhD, and Dominic Hodgkin, PhD. Am J Manag Care 1998; 4: S765-S769.
27. Cruickshank JM, Pennert K, Sorman AE, et al. Lowmortality from all causes, including myocardial infarction, in well-controlled hypertensives treated with a beta-blocker plus other antihypertensives. J Hypertens 1987; 5: 489-498.
28. Cruickshank JM. Antihypertensive treatment and the J-curve. Cardiovasc Drugs Ther 2000; 14: 373-379.
29. Greenlund KJ, Croft JB and Mensah G. Prevalence of heart disease and stroke risk factors in persons with prehypertension in the United States, 1999-2000. Arch Intern Med 2004; 164: 2113-2118.
30. Somes GW, Shorr RI and Pahor M. A new twist in the J-shape curve? J Am Geriatr Soc 1999; 47: 1477-1478.
31. Somes GW, Pahor M, Shorr RI, et al. The role of diastolic blood pressure when treating isolated systolic hypertension. Arch Intern Med 1999; 159: 2004-2009.
32. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group. Effects of intensive bloodpressure control in type 2 diabetes mellitus. N Engl J Med 2010; 362: 1575-1585.
33. Wright JT Jr, Agodoa L, Contreras G, et al. Successful blood pressure control in the African American Study of Kidney Disease and Hypertension. Arch Intern Med 2002; 162: 1636-1643.
34. National Heart, Lung, and Blood Institute (NHLBI). 2007, http://www.nhlbi.nih.gov/meetings/workshops/hypertension-sum.htm
35. Systolic Blood Pressure Intervention Trial (SPRINT). SPRINT protocol, 2012, https://www.sprinttrial.org/public/Protocol-Current.pdf
36. D'Agostino RB, Vasan RS and Pencina M. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation 2008; 117: 743-753.
37. Lindholm LH, Carlberg B and Samuelsson O. Should beta blockers remain first choice in the treatment of primary hypertension? A meta-analysis. Lancet 2005; 366: 1545-1553.
38. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in highrisk hypertensive patients randomized to angiotensinconverting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2981-2997.
39. Ernst ME, Carter BL, Goerdt CJ, et al. Comparative antihypertensive effects of hydrochlorothiazide and chlorthalidone on ambulatory and office blood pressure. Hypertension 2006; 47: 352-358.
40. Hypertension Detection and Follow-up Program Cooperative Group. Five-year findings of the hypertension detection and follow-up program. Reduction in mortality of persons with high blood pressure, including mild hypertension. JAMA 1997; 277: 157-166.
41. Dahlof B, Lindholm LH, Hansson L, et al. Morbidity and mortality in the Swedish Trial in Older Patients with Hypertension. Lancet 1991; 339: 1281-1285.
42. Iqbal SU, Rogers W, Selim A, et al. The Veterans RAND 12 Item Health Survey (VR-12): what it is and how it is used, 2007. Available at: http://www.hosonline.org/surveys/hos/download/Veterans-RAND-12-Item-Health-Survey-VR-12-2007.pdf.
43. Selim A, Rogers W, Fleishman J, et al. Updated U.S. population standard for the Veterans RAND 12-item ealth Survey (VR-12). Qual Life Res 2009; 18: 43-52.
44. Rabin R and de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001; 33: 337-343.
45. Kroenke K, Spitzer RL and Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001; 16: 606-613.
46. Spitzer RL, Kroenke K and Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. JAMA 1999; 282: 1737-1744.
47. Yardley L, Beyer N, Hauer K, et al. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing 2005; 34: 614-619.
48. Rosen R, Brown C, Heiman J, et al. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 2000; 26: 191-208.
49. Wiegel M, Meston C and Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marit Ther 2005; 31: 1-20.
50. Rosen RC, Cappelleri JC, Smith MD, et al. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res 1999; 11: 319-326.
51. Luepker RV, Apple FS, Christenson RH, et al. Case definitions for acute coronary heart disease in epidemiology and clinical research studies: a statement from the AHA Council on Epidemiology and Prevention; AHA Statistics Committee; World Heart Federation Council on Epidemiology and Prevention; the European Society of Cardiology Working Group on Epidemiology and Prevention; Centers for Disease Control and Prevention; and the National Heart, Lung, and Blood Institute. Circulation 2003; 108: 2543-2549.
52. Prineas RJ, Crow RS and Blackburn H. The Minnesota code manual of electrocardiographic findings. Boston, MA: John Wright PSB, 1982.
53. Easton J, Saver J, Albers GW, et al. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease: the American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. Stroke 2009; 40: 2276-2293.
54. World Health Organization. Cerebrovascular disorders: a clinical and research classification. Geneva: WHO Offset Publications, 1978. Available at: http://apps.who.int/iris/handle/10665/37194
55. Ay H, Benner T, Arsava EM, et al. A computerized algorithm for etiologic classification of ischemic stroke: the Causative Classification of Stroke System. Stroke 2007; 38: 2979-2984.
56. Gordon D, Bendixen B, Adams HJ, et al. Interphysician agreement in the diagnosis of subtypes of acute ischemic stroke: implications for clinical trials. The TOAST Investigators. Neurology 1993; 43: 1021-1027.
57. Rosamond WD, Chang P, Baggett C, et al. Classification of heart failure in the atherosclerosis risk in communities (ARIC) study: a comparison with other diagnostic criteria. Circulation 2009; 120: S506.
58. Pfeffer RI, Kurosaki TT, Harrah CH, et al. Measurement of functional activities in older adults in the community. J Gerontol 1982; 37: 323-329.
59. Nasreddine ZS, Phillips NA, Bedirian V, et al. TheMontreal Cognitive Assessment,MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005; 53: 695-699.
60. Rapp SR, Legault C, Espeland MA, et al. Validation of a cognitive assessment battery administered over the telephone. J Am Geriatr Soc 2012; 60: 1616-1623.
61. Welsh KA, Breitner JC and Magruder-Habib KM. Detection of dementia in the elderly using telephone screening of cognitive status. Neuropsychiatry Neuropsychol Behav Neurol 1993; 6: 103-110.
62. Kawas C, Segal J, Stewart WF, et al. A validation study of the Dementia Questionnaire. Arch Neurol 1994; 51: 901-906.
63. Proschan MA, Lan KKG and Wittes JT. Statistical monitoring of clinical trials: a unified approach. New York: Springer, 2006.
64. OHRP guidance on unanticipated problems and adverse events, 2007, http://www.hhs.gov/ohrp/policy/advevntguid.html
65. Code of Federal Regulations. Title 21: 21CFR312.32 (a). FDA, 2013, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32
66. Reboussin D and Espeland MA. The science of webbased clinical trial management. Clin Trials 2005; 2: 1-2.
67. Peters R, Beckett N, Forette F, et al. Incident dementia and blood pressure lowering in the Hypertension in the Very Elderly Trial cognitive function assessment (HYVET-COG): a double-blind, placebo controlled trial. Lancet Neurol 2008; 7: 683-689.
68. Krause T, Lovibond K, Caulfield M, et al. Management of hypertension: summary of NICE guidance. BMJ 2011; 343: d4891.
69. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 2014; 311(5): 507-520.
70. SPS3 Study Group, Benavente OR, Coffey CS, et al. Bloodpressure targets in patients with recent lacunar stroke: the SPS3 randomised trial. Lancet 2013; 382: 507-515.
71. Klahr S, Levey AS, Beck GJ, et al. The effects of dietary protein restriction and blood-pressure control on the progression of chronic renal disease. Modification of Diet in Renal Disease Study Group. N Engl J Med 1994; 330: 877-884.