Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial

Circulation: Heart Failure

Volumn 6, Issue 2, 2013, Pages 184-192

  Shah, Sanjiv J ^a   Heitner, John F ^b   Sweitzer, Nancy K ^c   Anand, Inder S ^d   Kim, Hae Young ^e   Harty, Brian ^e   Boineau, Robin ^f   Clausell, Nadine ^g   Desai, Akshay S ^h   Diaz, Rafael ⁱ   Fleg, Jerome L ^f   Gordeev, Ivan ^j   Lewis, Eldrin F ^h   Markov, Valetin ^k   O'Meara, Eileen ^l   Kobulia, Bondo ^m   Shaburishvili, Tamaz ⁿ   Solomon, Scott D ^h   Pitt, Bertram ^o   Pfeffer, Marc A ^h   Li, Rebecca ^e   more..

^a NORTHWESTERN UNIVERSITY   (United States)

^b NEW YORK METHODIST HOSPITAL   (United States)

^c UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^d UNIVERSITY OF MINNESOTA   (United States)

^e NEW ENGLAND RESEARCH INSTITUTES   (United States)

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

^g HOSPITAL DE CLÍNICAS DE PORTO ALEGRE   (Brazil)

^h BRIGHAM AND WOMEN S HOSPITAL   (United States)

ⁱ Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario   (Argentina)

^j Moscow State Institute   (Russian Federation)

^k TOMSK SCIENTIFIC CENTER   (Russian Federation)

^l MONTREAL HEART INSTITUTE   (Canada)

^m Institute of Cardiology   (Georgia)

ⁿ Diagnostic Services Clinic   (Georgia)

^o UNIVERSITY OF MICHIGAN   (United States)

more..

Author keywords

Aldosterone; Diastolic heart failure; Mineralocorticoid receptor; Randomized controlled trial; Spironolactone

Indexed keywords

ACETYLSALICYLIC ACID; ALDOSTERONE ANTAGONIST; AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; ANGIOTENSIN RECEPTOR ANTAGONIST; ANTIDIABETIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; NITRIC ACID DERIVATIVE; PLACEBO; WARFARIN; MINERALOCORTICOID ANTAGONIST; SPIRONOLACTONE;

ADULT; AGED; ARTICLE; BLOOD PRESSURE MEASUREMENT; BLOOD PRESSURE REGULATION; BODY MASS; CHRONIC KIDNEY DISEASE; COMORBIDITY; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DEPRESSION; DIABETES MELLITUS; DOUBLE BLIND PROCEDURE; DYSPNEA; ELECTROCARDIOGRAPHY; FEMALE; HEART ATRIUM FIBRILLATION; HEART FAILURE WITH PRESERVED EJECTION FRACTION; HEART LEFT VENTRICLE EJECTION FRACTION; HOSPITALIZATION; HUMAN; HYPERTENSION; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MULTICENTER STUDY; PHYSICAL EXAMINATION; PREVALENCE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RENIN ANGIOTENSIN ALDOSTERONE SYSTEM; SELF REPORT; SYSTOLIC BLOOD PRESSURE; ARGENTINA; CONTROLLED CLINICAL TRIAL; HEART FAILURE; HEART STROKE VOLUME; LIFESTYLE; MIDDLE AGED; PATHOPHYSIOLOGY; PREDICTIVE VALUE; QUESTIONNAIRE; TIME; TREATMENT OUTCOME; UNITED STATES; USSR;

AGED; ARGENTINA; COMORBIDITY; DEPRESSION; DOUBLE-BLIND METHOD; ELECTROCARDIOGRAPHY; FEMALE; HEART FAILURE; HUMANS; LIFE STYLE; MALE; MIDDLE AGED; MINERALOCORTICOID RECEPTOR ANTAGONISTS; PHYSICAL EXAMINATION; PREDICTIVE VALUE OF TESTS; QUALITY OF LIFE; QUESTIONNAIRES; SPIRONOLACTONE; STROKE VOLUME; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; USSR;

MLCS; MLOWN;

EID: 84877259591     PISSN: 19413289     EISSN: 19413297     Source Type: Journal    
DOI: 10.1161/CIRCHEARTFAILURE.112.972794     Document Type: Article

References (41)

1. Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2011 update: a report from the American Heart Association. Circulation. 2011;123:e18-e209.
2. Lam CS, Donal E, Kraigher-Krainer E, Vasan RS. Epidemiology and clinical course of heart failure with preserved ejection fraction. Eur J Heart Fail. 2011;13:18-28.
3. Maeder MT, Kaye DM. Heart failure with normal left ventricular ejection fraction. J Am Coll Cardiol. 2009;53:905-918.
4. Borlaug BA, Paulus WJ. Heart failure with preserved ejection fraction: pathophysiology, diagnosis, and treatment. Eur Heart J. 2011;32:670-679.
5. Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006;355:251-259.
6. Gottdiener JS, McClelland RL, Marshall R, Shemanski L, Furberg CD, Kitzman DW, Cushman M, Polak J, Gardin JM, Gersh BJ, Aurigemma GP, Manolio TA. Outcome of congestive heart failure in elderly persons: influence of left ventricular systolic function. The Cardiovascular Health Study. Ann Intern Med. 2002;137:631-639.
7. Bhatia RS, Tu JV, Lee DS, Austin PC, Fang J, Haouzi A, Gong Y, Liu PP. Outcome of heart failure with preserved ejection fraction in a populationbased study. N Engl J Med. 2006;355:260-269.
8. Yancy CW, Lopatin M, Stevenson LW, De Marco T, Fonarow GC; ADHERE Scientific Advisory Committee and Investigators. Clinical presentation, management, and in-hospital outcomes of patients admitted with acute decompensated heart failure with preserved systolic function: a report from the Acute Decompensated Heart Failure National Registry (ADHERE) Database. J Am Coll Cardiol. 2006;47:76-84.
9. Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE- HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007;50:768-777.
10. Shah SJ, Gheorghiade M. Heart failure with preserved ejection fraction: treat now by treating comorbidities. JAMA. 2008;300:431-433.
11. Kitzman DW, Little WC, Brubaker PH, Anderson RT, Hundley WG, Marburger CT, Brosnihan B, Morgan TM, Stewart KP. Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. JAMA. 2002;288:2144-2150.
12. Hoekstra T, Lesman-Leegte I, van Veldhuisen DJ, Sanderman R, Jaarsma T. Quality of life is impaired similarly in heart failure patients with preserved and reduced ejection fraction. Eur J Heart Fail. 2011;13:1013-1018.
13. Lewis EF, Lamas GA, O'Meara E, Granger CB, Dunlap ME, McKelvie RS, Probstfield JL, Young JB, Michelson EL, Halling K, Carlsson J, Olofsson B, McMurray JJ, Yusuf S, Swedberg K, Pfeffer MA; CHARM Investigators. Characterization of health-related quality of life in heart failure patients with preserved versus low ejection fraction in CHARM. Eur J Heart Fail. 2007;9:83-91.
14. Ahmed A, Rich MW, Fleg JL, Zile MR, Young JB, Kitzman DW, Love TE, Aronow WS, Adams KF Jr, Gheorghiade M. Effects of digoxin on morbidity and mortality in diastolic heart failure: the Ancillary Digitalis Investigation Group trial. Circulation. 2006;114:397-403.
15. Flather MD, Shibata MC, Coats AJ, Van Veldhuisen DJ, Parkhomenko A, Borbola J, Cohen-Solal A, Dumitrascu D, Ferrari R, Lechat P, Soler-Soler J, Tavazzi L, Spinarova L, Toman J, Böhm M, Anker SD, Thompson SG, Poole-Wilson PA; SENIORS Investigators. Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS). Eur Heart J. 2005;26:215-225.
16. van Veldhuisen DJ, Cohen-Solal A, Böhm M, Anker SD, Babalis D, Roughton M, Coats AJ, Poole-Wilson PA, Flather MD; SENIORS Investigators. Beta-blockade with nebivolol in elderly heart failure patients with impaired and preserved left ventricular ejection fraction: data from SENIORS (Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalization in Seniors With Heart Failure). J Am Coll Cardiol. 2009;53:2150-2158.
17. Cleland JG, Tendera M, Adamus J, Freemantle N, Polonski L, Taylor J; PEP-CHF Investigators. The Perindopril in Elderly People With Chronic Heart Failure (PEP-CHF) study. Eur Heart J. 2006;27:2338-2345.
18. Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, Michelson EL, Olofsson B, Ostergren J; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet. 2003;362:777-781.
19. Pitt B. The role of mineralocorticoid receptor antagonists (MRAs) in very old patients with heart failure. Heart Fail Rev. 2012;17:573-579.
20. Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999;341:709-717.
21. Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011;364:11-21.
22. Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003;348:1309-1321.
23. Mottram PM, Haluska B, Leano R, Cowley D, Stowasser M, Marwick TH. Effect of aldosterone antagonism on myocardial dysfunction in hypertensive patients with diastolic heart failure. Circulation. 2004;110:558-565.
24. Roongsritong C, Sutthiwan P, Bradley J, Simoni J, Power S, Meyerrose GE. Spironolactone improves diastolic function in the elderly. Clin Cardiol. 2005;28:484-487.
25. 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;106:1505-1511.
26. Sato A, Hayashi M, Saruta T. Relative long-term effects of spironolactone in conjunction with an angiotensin-converting enzyme inhibitor on left ventricular mass and diastolic function in patients with essential hypertension. Hypertens Res. 2002;25:837-842.
27. Desai AS, Lewis EF, Li R, Solomon SD, Assmann SF, Boineau R, Clausell N, Diaz R, Fleg JL, Gordeev I, McKinlay S, O'Meara E, Shaburishvili T, Pitt B, Pfeffer MA. Rationale and design of the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial: a randomized, controlled study of spironolactone in patients with symptomatic heart failure and preserved ejection fraction. Am Heart J. 2011;162:966-972.e10.
28. Wolf AM, Hunter DJ, Colditz GA, Manson JE, Stampfer MJ, Corsano KA, Rosner B, Kriska A, Willett WC. Reproducibility and validity of a self-administered physical activity questionnaire. Int J Epidemiol. 1994;23:991-999.
29. Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000;35:1245-1255.
30. Glick HA, Polsky D, Willke RJ, Schulman KA. A comparison of preference assessment instruments used in a clinical trial: responses to the visual analog scale from the EuroQol EQ-5D and the Health Utilities Index. Med Decis Making. 1999;19:265-275.
31. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16:606-613.
32. Rector TS, Carson PE, Anand IS, McMurray JJ, Zile MR, McKelvie RS, Komajda M, Kuskowski M, Massie BM; I-PRESERVE Trial Investigators. Assessment of long-term effects of irbesartan on heart failure with preserved ejection fraction as measured by the minnesota living with heart failure questionnaire in the Irbesartan in Heart Failure With Preserved Systolic Function (I-PRESERVE) trial. Circ Heart Fail. 2012;5:217-225.
33. McMurray JJ, Carson PE, Komajda M, McKelvie R, Zile MR, Ptaszynska A, Staiger C, Donovan JM, Massie BM. Heart failure with preserved ejection fraction: clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial. Eur J Heart Fail. 2008;10:149-156.
34. Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; IPRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008;359:2456-2467.
35. McMurray J, Ostergren J, Pfeffer M, Swedberg K, Granger C, Yusuf S, Held P, Michelson E, Olofsson B; CHARM committees and investigators. Clinical features and contemporary management of patients with low and preserved ejection fraction heart failure: baseline characteristics of patients in the Candesartan in Heart failure-Assessment of Reduction in Mortality and Morbidity (CHARM) programme. Eur J Heart Fail. 2003;5:261-270.
36. Lee DS, Gona P, Vasan RS, Larson MG, Benjamin EJ, Wang TJ, Tu JV, Levy D. Relation of disease pathogenesis and risk factors to heart failure with preserved or reduced ejection fraction: insights from the framingham heart study of the national heart, lung, and blood institute. Circulation. 2009;119:3070-3077.
37. Ku E, Campese VM. Aldosterone and hypertension in African Americans. Am J Hypertens. 2009;22:1234.
38. ALLHAT Collaborative Research Group.Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT Collaborative Research Group. Jama. 2000;283:1967-1975.
39. Anand IS, Rector TS, Cleland JG, Kuskowski M, McKelvie RS, Persson H, McMurray JJ, Zile MR, Komajda M, Massie BM, Carson PE. Prognostic value of baseline plasma amino-terminal pro-brain natriuretic peptide and its interactions with irbesartan treatment effects in patients with heart failure and preserved ejection fraction: findings from the I-PRESERVE trial. Circ Heart Fail. 2011;4: 569-577.
40. Rogers JG, Aaronson KD, Boyle AJ, Russell SD, Milano CA, Pagani FD, Edwards BS, Park S, John R, Conte JV, Farrar DJ, Slaughter MS; HeartMate II Investigators. Continuous flow left ventricular assist device improves functional capacity and quality of life of advanced heart failure patients. J Am Coll Cardiol. 2010;55:1826-1834.
41. Manns BJ, Walsh MW, Culleton BF, Hemmelgarn B, Tonelli M, Schorr M, Klarenbach S; Alberta Kidney Disease Network. Nocturnal hemodialysis does not improve overall measures of quality of life compared to conventional hemodialysis. Kidney Int. 2009;75:542-549. Blood Institute