Correction: Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial–a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial (Trials, (2014), 15, 1, (160), 10.1186/1745-6215-15-160);Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial-a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular o

Trials

Volumn 15, Issue 1, 2014, Pages

  Hill, Nathan R ^a,b   Lasserson, Daniel ^a,b   Thompson, Ben ^a   Perera Salazar, Rafael ^a   Wolstenholme, Jane ^c   Bower, Peter ^d   Blakeman, Thomas ^d   Fitzmaurice, David ^e   Little, Paul ^f   Feder, Gene ^g   Qureshi, Nadeem ^h   Taal, Maarten ⁱ   Townend, Jonathan ^j   Ferro, Charles ^j   McManus, Richard ^a   Hobbs, FD R ^a,b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b NIHR OXFORD BIOMEDICAL RESEARCH CENTRE   (United Kingdom)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d UNIVERSITY OF MANCHESTER   (United Kingdom)

^e UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^f UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^g UNIVERSITY OF BRISTOL   (United Kingdom)

^h UNIVERSITY OF NOTTINGHAM   (United Kingdom)

ⁱ ROYAL DERBY HOSPITAL   (United Kingdom)

^j QUEEN ELIZABETH HOSPITAL   (United Kingdom)

more..

Author keywords

Cardiovascular disease; Chronic kidney disease; CKD aldosterone receptor antagonist; CKD mortality

Indexed keywords

SPIRONOLACTONE; MINERALOCORTICOID ANTAGONIST;

ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CHRONIC KIDNEY DISEASE; CLINICAL PROTOCOL; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DISEASE COURSE; DRUG EFFECT; DRUG EFFICACY; FEMALE; GLOMERULUS FILTRATION RATE; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; OPEN STUDY; PRIMARY MEDICAL CARE; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; CARDIOVASCULAR DISEASES; CLINICAL TRIAL; COMPLICATION; DRUG ADMINISTRATION; GREAT BRITAIN; METHODOLOGY; PRIMARY HEALTH CARE; PROSPECTIVE STUDY; RENAL INSUFFICIENCY, CHRONIC; RISK FACTOR; SEVERITY OF ILLNESS INDEX; TIME FACTOR;

CARDIOVASCULAR DISEASES; CLINICAL PROTOCOLS; DISEASE PROGRESSION; DRUG ADMINISTRATION SCHEDULE; FEMALE; GREAT BRITAIN; HUMANS; MALE; MINERALOCORTICOID RECEPTOR ANTAGONISTS; PRIMARY HEALTH CARE; PROSPECTIVE STUDIES; RENAL INSUFFICIENCY, CHRONIC; RESEARCH DESIGN; RISK FACTORS; SEVERITY OF ILLNESS INDEX; SPIRONOLACTONE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84900310067     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-022-06972-9     Document Type: Erratum

References (53)

1. de Lusignan S, Tomson C, Harris K, van Vlymen J, Gallagher H. Creatinine fluctuation has a greater effect than the formula to estimate glomerular filtration rate on the prevalence of chronic kidney disease. Nephron Clin Pract 2011, 117(3):c213-c224. 10.1159/000320341, 20805694.
2. de Lusignan S, Tomson C, Harris K, van Vlymen J, Gallagher H. UK Prevalence of chronic kidney disease for the adult population is 6.76% based on two creatinine readings [Erratum]. Nephron Clin Pract 2012, 120:c107.
3. Gansevoort RT, Correa-Rotter R, Hemmelgarn BR, Jafar TH, Heerspink HJ, Mann JF, Matsushita K, Wen CP. Chronic kidney disease and cardiovascular risk: epidemiology, mechanisms, and prevention. Lancet 2013, 382(9889):339-352. 10.1016/S0140-6736(13)60595-4, 23727170.
4. Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA 2007, 298(17):2038-2047. 10.1001/jama.298.17.2038, 17986697.
5. KDOQI KDOQI. Chronic Kidney Disease Evaluation, Classification, and Stratification 2002, [http://www.kidney.org/professionals/kdoqi/guidelines_commentaries.cfm], KDOQI KDOQI. Chronic Kidney Disease.
6. De Lusignan S, Gallagher H, Chan T, Thomas N, van Vlymen J, Nation M, Jain N, Tahir A, Du Bois E, Crinson I, Hague N, Reid F, Harris K. The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD) in primary care. Implementation Sci 2009, 4:39.
7. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999, 130(6):461-470. 10.7326/0003-4819-130-6-199903160-00002, 10075613.
8. Hallan SI, Dahl K, Oien CM, Grootendorst DC, Aasberg A, Holmen J, Dekker FW. Screening strategies for chronic kidney disease in the general population: follow-up of cross sectional health survey. BMJ 2006, 333(7577):1047. 10.1136/bmj.39001.657755.BE, 1647344, 17062598.
9. Coresh J, Byrd-Holt D, Astor BC, Briggs JP, Eggers PW, Lacher DA, Hostetter TH. Chronic kidney disease awareness, prevalence, and trends among U.S. adults, 1999 to 2000. J Am Soc Nephrol 2005, 16(1):180-188.
10. Coresh J, Astor BC, Greene T, Eknoyan G, Levey AS. Prevalence of chronic kidney disease and decreased kidney function in the adult US population: Third National Health and Nutrition Examination Survey. Am J Kidney Dis 2003, 41(1):1-12. 10.1053/ajkd.2003.50007, 12500213.
11. Keith DS, Nichols GA, Gullion CM, Brown JB, Smith DH. Longitudinal follow-up and outcomes among a population with chronic kidney disease in a large managed care organization. Arch Intern Med 2004, 164(6):659-663. 10.1001/archinte.164.6.659, 15037495.
12. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med 2004, 351(13):1296-1305. 10.1056/NEJMoa041031, 15385656.
13. Chronic Kidney Disease Prognosis C, Matsushita K, van der Velde M, Astor BC, Woodward M, Levey AS, de Jong PE, Coresh J, Gansevoort RT. Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis. Lancet 2010, 375(9731):2073-2081. 3993088, 20483451.
14. Abramson JL, Jurkovitz CT, Vaccarino V, Weintraub WS, McClellan W. Chronic kidney disease, anemia, and incident stroke in a middle-aged, community-based population: the ARIC Study. Kidney Int 2003, 64(2):610-615. 10.1046/j.1523-1755.2003.00109.x, 12846757.
15. Van Biesen W, De Bacquer D, Verbeke F, Delanghe J, Lameire N, Vanholder R. The glomerular filtration rate in an apparently healthy population and its relation with cardiovascular mortality during 10 years. Eur Heart J 2007, 28(4):478-483. 10.1093/eurheartj/ehl455, 17223665.
16. OCallaghan CA, Shine B, Lasserson DS. Chronic kidney disease: a large-scale population-based study of the effects of introducing the CKD-EPI formula for eGFR reporting. BMJ Open 2011, 1(2):e000308. 3244664, 22184586.
17. Foley RN, Curtis BM, Randell EW, Parfrey PS. Left ventricular hypertrophy in new hemodialysis patients without symptomatic cardiac disease. Clin J Am Soc Nephrol 2010, 5(5):805-813. 10.2215/CJN.07761109, 2863966, 20378644.
18. Foley RN, Murray AM, Li S, Herzog CA, McBean AM, Eggers PW, Collins AJ. Chronic kidney disease and the risk for cardiovascular disease, renal replacement, and death in the United States Medicare population, 1998 to 1999. J Am Soc Nephrol 2005, 16(2):489-495. 10.1681/ASN.2004030203, 15590763.
19. Collins AJ, Li S, Gilbertson DT, Liu J, Chen SC, Herzog CA. Chronic kidney disease and cardiovascular disease in the Medicare population. Kidney Int Suppl 2003, 87:S24-S31.
20. Muntner P, He J, Astor BC, Folsom AR, Coresh J. Traditional and nontraditional risk factors predict coronary heart disease in chronic kidney disease: results from the atherosclerosis risk in communities study. J Am Soc Nephrol 2005, 16(2):529-538. 10.1681/ASN.2004080656, 15625072.
21. Mourad JJ, Pannier B, Blacher J, Rudnichi A, Benetos A, London GM, Safar ME. Creatinine clearance, pulse wave velocity, carotid compliance and essential hypertension. Kidney Int 2001, 59(5):1834-1841. 10.1046/j.1523-1755.2001.0590051834.x, 11318954.
22. Edwards NC, Ferro CJ, Townend JN, Steeds RP. Aortic distensibility and arterial-ventricular coupling in early chronic kidney disease: a pattern resembling heart failure with preserved ejection fraction. Heart 2008, 94(8):1038-1043. 10.1136/hrt.2007.137539, 18308865.
23. NICE NIfCE. Chronic Kidney Disease (Update) Draft Guideline 2014, [http://guidance.nice.org.uk/CG/WaveR/130/Consultation/Latest], NICE NIfCE. Chronic Kidney Disease (Update).
24. Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, Neal B, Jiang L, Hooi LS, Levin A, Agodoa L, Gaziano M, Kasiske B, Walker R, Massy ZA, Feldt-Rasmussen B, Krairittichai U, Ophascharoensuk V, Fellström B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Grönhagen-Riska C, Dasgupta T, et al. SHARP Investigators The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet 2011, 377(9784):2181-2192. 10.1016/S0140-6736(11)60739-3, 3145073, 21663949, SHARP Investigators.
25. Investigators SOLVD. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. The SOLVD Investigators. N Engl J Med 1991, 325(5):293-302.
26. Tonelli M, Wiebe N, Culleton B, House A, Rabbat C, Fok M, McAlister F, Garg AX. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol 2006, 17(7):2034-2047. 10.1681/ASN.2005101085, 16738019.
27. Edwards NC, Ferro CJ, Kirkwood H, Chue CD, Young AA, Stewart PM, Steeds RP, Townend JN. Effect of spironolactone on left ventricular systolic and diastolic function in patients with early stage chronic kidney disease. Am J Cardiol 2010, 106(10):1505-1511. 10.1016/j.amjcard.2010.07.018, 21059444.
28. Farquharson CA, Struthers AD. Spironolactone increases nitric oxide bioactivity, improves endothelial vasodilator dysfunction, and suppresses vascular angiotensin I/angiotensin II conversion in patients with chronic heart failure. Circulation 2000, 101(6):594-597. 10.1161/01.CIR.101.6.594, 10673249.
29. Vukusich A, Kunstmann S, Varela C, Gainza D, Bravo S, Sepulveda D, Cavada G, Michea L, Marusic ET. A randomized, double-blind, placebo-controlled trial of spironolactone on carotid intima-media thickness in nondiabetic hemodialysis patients. Clin J Am Soc Nephrol 2010, 5(8):1380-1387. 10.2215/CJN.09421209, 2924413, 20522535.
30. Pitt B. Pharmacotherapy: Cardiovascular effects of aldosterone blockade in CKD. Nat Rev Cardiol 2009, 6(11):679-680. 10.1038/nrcardio.2009.175, 19851348.
31. Herzog CA. Kidney disease in cardiology. Nephrology, dialysis, transplantation: official publication of the European Dialysis and Transplant Association. Eur Renal Assoc 2011, 26(1):46-50.
32. Chapman N, Dobson J, Wilson S, Dahlöf B, Sever PS, Wedel H, Poulter NR, Anglo-Scandinavian Cardiac Outcomes Trial Investigators Effect of spironolactone on blood pressure in subjects with resistant hypertension. Hypertension 2007, 49(4):839-845. 10.1161/01.HYP.0000259805.18468.8c, 17309946, Anglo-Scandinavian Cardiac Outcomes Trial Investigators.
33. Casas JP, Chua W, Loukogeorgakis S, Vallance P, Smeeth L, Hingorani AD, MacAllister RJ. Effect of inhibitors of the renin-angiotensin system and other antihypertensive drugs on renal outcomes: systematic review and meta-analysis. Lancet 2005, 366(9502):2026-2033. 10.1016/S0140-6736(05)67814-2, 16338452.
34. Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med 2000, 342(3):145-153.
35. National Kidney Foundation N K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis 2002, 39(2 Suppl 1):S1-S266. National Kidney Foundation N.
36. SIGN Diagnosis and Management of Chronic Kidney Disease 2008, [http://www.sign.ac.uk/guidelines/fulltext/103/], SIGN.
37. NICE NIfCE CG73 Chronic Kidney Disease: Full Guideline 2008, [http://guidance.nice.org.uk/CG73/Guidance/pdf/English], NICE NIfCE.
38. Brown NJ. Eplerenone: cardiovascular protection. Circulation 2003, 107(19):2512-2518. 10.1161/01.CIR.0000071081.35693.9A, 12756192.
39. Funder JW, Mihailidou AS. Aldosterone and mineralocorticoid receptors: Clinical studies and basic biology. Mol Cell Endocrinol 2009, 301(1-2):2-6.
40. Struthers AD. Aldosterone: cardiovascular assault. Am Heart J 2002, 144(5 Suppl):S2-S7.
41. Robert V, Silvestre JS, Charlemagne D, Sabri A, Trouvé P, Wassef M, Swynghedauw B, Delcayre C. Biological determinants of aldosterone-induced cardiac fibrosis in rats. Hypertension 1995, 26(6 Pt 1):971-978.
42. Catena C, Colussi G, Lapenna R, Nadalini E, Chiuch A, Gianfagna P, Sechi LA. Long-term cardiac effects of adrenalectomy or mineralocorticoid antagonists in patients with primary aldosteronism. Hypertension 2007, 50(5):911-918. 10.1161/HYPERTENSIONAHA.107.095448, 17893375.
43. Milliez P, Girerd X, Plouin PF, Blacher J, Safar ME, Mourad JJ. Evidence for an increased rate of cardiovascular events in patients with primary aldosteronism. J Am Coll Cardiol 2005, 45(8):1243-1248. 10.1016/j.jacc.2005.01.015, 15837256.
44. Palmer BR, Pilbrow AP, Frampton CM, Yandle TG, Skelton L, Nicholls MG, Richards AM. Plasma aldosterone levels during hospitalization are predictive of survival post-myocardial infarction. Eur Heart J 2008, 29(20):2489-2496. 10.1093/eurheartj/ehn383, 18757359.
45. Tomaschitz A, Pilz S, Ritz E, Meinitzer A, Boehm BO, März W. Plasma aldosterone levels are associated with increased cardiovascular mortality: the Ludwigshafen Risk and Cardiovascular Health (LURIC) study. Eur Heart J 2010, 31(10):1237-1247. 10.1093/eurheartj/ehq019, 20200015.
46. Navaneethan SD, Nigwekar SU, Sehgal AR, Strippoli GF. Aldosterone antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev 2009, 3. CD007004.
47. Matsumoto Y, Kageyama S, Yakushigawa T, Arihara K, Sugiyama T, Mori Y, Sugiyama H, Ohmura H, Shio N. Long-term low-dose spironolactone therapy is safe in oligoanuric hemodialysis patients. Cardiology 2009, 114(1):32-38. 10.1159/000210553, 19342857.
48. London GM, Blacher J, Pannier B, Guerin AP, Marchais SJ, Safar ME. Arterial wave reflections and survival in end-stage renal failure. Hypertension 2001, 38(3):434-438. 10.1161/01.HYP.38.3.434, 11566918.
49. Joint Formulary Committee British National Formulary 2012, London: BMJ Publishing Group Ltd and Royal Pharmaceutical Society, Joint Formulary Committee.
50. Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, Hatsukami TS, Higashida RT, Johnston SC, Kidwell CS, Lutsep HL, Miller E, Sacco RL, American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Interdisciplinary Council on Peripheral Vascular Disease 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(6):2276-2293. 10.1161/STROKEAHA.108.192218, 19423857, American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Interdisciplinary Council on Peripheral Vascular Disease.
51. Zannad F, Alla F, Dousset B, Perez A, Pitt B. Limitation of excessive extracellular matrix turnover may contribute to survival benefit of spironolactone therapy in patients with congestive heart failure: insights from the randomized aldactone evaluation study (RALES). Rales Investigators. Circulation 2000, 102(22):2700-2706. 10.1161/01.CIR.102.22.2700, 11094035.
52. Latimer NR. NICE DSU Technical Support Document 14: Survival Analysis for Economic Evaluations Alongside Clinical Trials-Extrapolation with Patient Level Data 2011, Sheffield: School of Health and Related Research, University of Sheffield.
53. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c869. 10.1136/bmj.c869, 2844943, 20332511.