Interleukin-1 blockade in recently decompensated systolic heart failure: Results from REDHART (Recently Decompensated Heart Failure Anakinra Response Trial)

Circulation: Heart Failure

Volumn 10, Issue 11, 2017, Pages

  Van Tassell, Benjamin W ^a   Canada, Justin ^a   Carbone, Salvatore ^a,b   Trankle, Cory ^a   Buckley, Leo ^a   Erdle, Claudia Oddi ^a   Abouzaki, Nayef A ^a   Dixon, Dave ^a   Kadariya, Dinesh ^a   Christopher, Sanah ^a   Schatz, Aaron ^a   Regan, Jessica ^a   Viscusi, Michele ^a   Del Buono, Marco ^a   Melchior, Ryan ^a   Mankad, Pranav ^a   Lu, Juan ^a   Sculthorpe, Robin ^a   Biondi Zoccai, Giuseppe ^c,d   Lesnefsky, Edward ^a,e   Arena, Ross ^f   Abbate, Antonio ^a   more..

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^b SAPIENZA UNIVERSITY OF ROME   (Italy)

^c SAPIENZA UNIVERSITY OF ROME   (Italy)

^d IRCCS NEUROMED   (Italy)

^e VETERANS AFFAIRS MEDICAL CENTER   (United States)

^f UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

Author keywords

Heart failure; Inflammation; Interleukin 1; Myocardial infarction; Systolic

Indexed keywords

ANAKINRA; C REACTIVE PROTEIN; INTERLEUKIN 1; PLACEBO; ANTIINFLAMMATORY AGENT; AUTACOID; BIOLOGICAL MARKER; INTERLEUKIN 1 RECEPTOR BLOCKING AGENT;

ACUTE HEART INFARCTION; ACUTE KIDNEY FAILURE; AEROBIC EXERCISE; ARTICLE; BLOOD CELL COUNT; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CARDIOPULMONARY EXERCISE TEST; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DOPPLER ECHOCARDIOGRAPHY; DYSPNEA; FOLLOW UP; HEART LEFT VENTRICLE EJECTION FRACTION; HEART SUPRAVENTRICULAR ARRHYTHMIA; HOSPITALIZATION; HUMAN; INFLAMMATION; LUNG CONGESTION; MAJOR CLINICAL STUDY; MORTALITY; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY DISTRESS; SEPSIS; SYSTOLIC HEART FAILURE; TACHYPNEA; THORAX RADIOGRAPHY; AGED; ANTAGONISTS AND INHIBITORS; BLOOD; COMPARATIVE STUDY; CONVALESCENCE; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; DRUG EFFECTS; EXERCISE TEST; EXERCISE TOLERANCE; FEMALE; HEART FAILURE; HEART LEFT VENTRICLE FUNCTION; HEART STROKE VOLUME; MALE; METABOLISM; MIDDLE AGED; OXYGEN CONSUMPTION; PATHOPHYSIOLOGY; QUESTIONNAIRE; TIME FACTOR; TREATMENT OUTCOME; VIRGINIA;

AGED; ANTI-INFLAMMATORY AGENTS; BIOMARKERS; C-REACTIVE PROTEIN; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; ECHOCARDIOGRAPHY, DOPPLER; EXERCISE TEST; EXERCISE TOLERANCE; FEMALE; HEART FAILURE; HUMANS; INFLAMMATION MEDIATORS; INTERLEUKIN 1 RECEPTOR ANTAGONIST PROTEIN; INTERLEUKIN-1; MALE; MIDDLE AGED; OXYGEN CONSUMPTION; QUALITY OF LIFE; RECOVERY OF FUNCTION; STROKE VOLUME; SURVEYS AND QUESTIONNAIRES; TIME FACTORS; TREATMENT OUTCOME; VENTRICULAR FUNCTION, LEFT; VIRGINIA;

EID: 85038008239     PISSN: 19413289     EISSN: 19413297     Source Type: Journal    
DOI: 10.1161/CIRCHEARTFAILURE.117.004373     Document Type: Article

References (35)

1. Keenan PS, Normand SL, Lin Z, Drye EE, Bhat KR, Ross JS, Schuur JD, Stauffer BD, Bernheim SM, Epstein AJ, Wang Y, Herrin J, Chen J, Federer JJ, Mattera JA, Wang Y, Krumholz HM. An administrative claims measure suitable for profiling hospital performance on the basis of 30-day all-cause readmission rates among patients with heart failure. Circ Cardiovasc Qual Outcomes. 2008;1:29-37. doi: 10.1161/CIRCOUTCOMES.108.802686.
2. Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Piña IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013;6:606-619. doi: 10.1161/HHF.0b013e318291329a.
3. Van Tassell BW, Raleigh JM, Abbate A. Targeting interleukin-1 in heart failure and inflammatory heart disease. Curr Heart Fail Rep. 2015;12:33-41. doi: 10.1007/s11897-014-0231-7.
4. Van Tassell BW, Toldo S, Mezzaroma E, Abbate A. Targeting interleukin- 1 in heart disease. Circulation. 2013;128:1910-1923. doi: 10.1161 CIRCULATIONAHA.113.003199.
5. Van Tassell BW, Arena RA, Toldo S, Mezzaroma E, Azam T, Seropian IM, Shah K, Canada J, Voelkel NF, Dinarello CA, Abbate A. Enhanced interleukin- 1 activity contributes to exercise intolerance in patients with systolic heart failure. PLoS One. 2012;7:e33438. doi: 10.1371/journal. pone.0033438.
6. Van Tassell BW, Arena R, Biondi-Zoccai G, Canada JM, Oddi C, Abouzaki NA, Jahangiri A, Falcao RA, Kontos MC, Shah KB, Voelkel NF, Dinarello CA, Abbate A. Effects of interleukin-1 blockade with anakinra on aerobic exercise capacity in patients with heart failure and preserved ejection fraction (from the D-HART pilot study). Am J Cardiol. 2014;113:321-327. doi: 10.1016/j.amjcard.2013.08.047.
7. Van Tassell BW, Abouzaki NA, Oddi Erdle C, Carbone S, Trankle CR, Melchior RD, Turlington JS, Thurber CJ, Christopher S, Dixon DL, Fronk DT, Thomas CS, Rose SW, Buckley LF, Dinarello CA, Biondi-Zoccai G, Abbate A. Interleukin-1 blockade in acute decompensated heart failure: a randomized, double-blinded, placebo-controlled pilot study. J Cardiovasc Pharmacol. 2016;67:544-551. doi: 10.1097/FJC.0000000000000378.
8. Van Tassell BW, Raleigh JV, Oddi C, Carbone S, Canada J, Abouzaki NA, Biondi-Zoccai GGL, Arena RA, Abbate A. Interleukin-1 blockade in recently decompensated heart failure: study design of the Recently Decompensated Heart Failure Anakinra Response Trial (REDHART). J Clin Trials Cardiol. 2015;2:1-8.
9. US Department of Health and Human Services Food and Drug Administration. Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees. https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127073.pdf. Accessed October 19, 2017.
10. Arena R, Humphrey R, Peberdy MA, Madigan M. Predicting peak oxygen consumption during a conservative ramping protocol: implications for the heart failure population. J Cardiopulm Rehabil. 2003;23:183-189.
11. Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010;122:191-225. doi: 10.1161/CIR.0b013e3181e52e69.
12. Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Piña IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001;104:1694-1740.
13. Gardin JM, Adams DB, Douglas PS, Feigenbaum H, Forst DH, Fraser AG, Grayburn PA, Katz AS, Keller AM, Kerber RE, Khandheria BK, Klein AL, Lang RM, Pierard LA, Quinones MA, Schnittger I; American Society of Echocardiography. Recommendations for a standardized report for adult transthoracic echocardiography: a report from the American Society of Echocardiography's Nomenclature and Standards Committee and Task Force for a Standardized Echocardiography Report. J Am Soc Echocardiogr. 2002;15:275-290. doi: 10.1067/mje.2002.121536.
14. Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005;18:1440-1463. doi: 10.1016/j.echo.2005.10.005.
15. Broch O, Renner J, Gruenewald M, Meybohm P, Schöttler J, Caliebe A, Steinfath M, Malbrain M, Bein B. A comparison of the Nexfin® and transcardiopulmonary thermodilution to estimate cardiac output during coronary artery surgery. Anaesthesia. 2012;67:377-383. doi: 10.1111/j.1365- 2044.2011.07018.x.
16. Schwartzenberg S, Redfield MM, From AM, Sorajja P, Nishimura RA, Borlaug BA. Effects of vasodilation in heart failure with preserved or reduced ejection fraction implications of distinct pathophysiologies on response to therapy. J Am Coll Cardiol. 2012;59:442-451. doi: 10.1016/j.jacc.2011.09.062.
17. Chen CH, Fetics B, Nevo E, Rochitte CE, Chiou KR, Ding PA, Kawaguchi M, Kass DA. Noninvasive single-beat determination of left ventricular endsystolic elastance in humans. J Am Coll Cardiol. 2001;38:2028-2034.
18. Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989;64:651-654.
19. Rector TS, Kubo SH, Cohn JN. Patients' self-assessment of their congestive heart failure. Part 2: content, reliability and validity of a new measure, the Minnesota living with heart failure questionnaire. Heart Failure. 1987;3:198-209.
20. Hicks KA, Tcheng JE, Bozkurt B, Chaitman BR, Cutlip DE, Farb A, Fonarow GC, Jacobs JP, Jaff MR, Lichtman JH, Limacher MC, Mahaffey KW, Mehran R, Nissen SE, Smith EE, Targum SL; American College of Cardiology; American Heart Association. 2014 ACC/AHA key data elements and definitions for cardiovascular endpoint events in clinical trials: a report of the American College of Cardiology/American Heart Association Task Force on clinical data standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). Circulation. 2015;132:302-361. doi: 10.1161/CIR.0000000000000156.
21. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BR, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction; Authors/Task Force Members Chairpersons; Biomarker Subcommittee; ECG Subcommittee; Imaging Subcommittee; Classification Subcommittee; Intervention Subcommittee; Trials & Registries Subcommittee; Trials & Registries Subcommittee; Trials & Registries Subcommittee; Trials & Registries Subcommittee; ESC Committee for Practice Guidelines (CPG); Document Reviewers. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012;60:1581-1598. doi: 10.1016/j.jacc.2012.08.001.
22. Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS V, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters H V. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44:2064-2089.
23. Anker SD, Coats AJ, Cristian G, Dragomir D, Pusineri E, Piredda M, Bettari L, Dowling R, Volterrani M, Kirwan BA, Filippatos G, Mas JL, Danchin N, Solomon SD, Lee RJ, Ahmann F, Hinson A, Sabbah HN, Mann DL. A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial). Eur Heart 2015;36:2297-2309. doi: 10.1093/eurheartj/ehv259.
24. Lepore JJ, Olson E, Demopoulos L, Haws T, Fang Z, Barbour AM, Fossler M, Davila-Roman VG, Russell SD, Gropler REffects of the novel longacting GLP-1 agonist, albiglutide, on cardiac function, cardiac metabolism, and exercise capacity in patients with chronic heart failure and reduced ejection fraction. JACC Heart Fail. 2016;4:559-566. doi: 10.1016/j.jchf.2016.01.008.
25. Bensimhon DR, Leifer ES, Ellis SJ, Fleg JL, Keteyian SJ, Piña IL, Kitzman DW, McKelvie RS, Kraus WE, Forman DE, Kao AJ, Whellan DJ, O'Connor CM, Russell SD; HF-ACTION Trial Investigators. Reproducibility of peak oxygen uptake and other cardiopulmonary exercise testing parameters in patients with heart failure (from the Heart Failure and A Controlled Trial Investigating Outcomes of exercise traiNing). Am J Cardiol. 2008;102:712-717. doi: 10.1016/j.amjcard.2008.04.047.
26. Tate CW III, Robertson AD, Zolty R, Shakar SF, Lindenfeld J, Wolfel EE, Bristow MR, Lowes BD. Quality of life and prognosis in heart failure: results of the Beta-Blocker Evaluation of Survival Trial (BEST). J Card Fail. 2007;13:732-737. doi: 10.1016/j.cardfail.2007.07.001.
27. He Y. Missing data analysis using multiple imputation: getting to the heart of the matter. Circ Cardiovasc Qual Outcomes. 2010;3:98-105. doi: 10.1161/CIRCOUTCOMES.109.875658.
28. Guazzi M, De Vita S, Cardano P, Barlera S, Guazzi MD. Normalization for peak oxygen uptake increases the prognostic power of the ventilatory response to exercise in patients with chronic heart failure. Am Heart 2003;146:542-548. doi: 10.1016/S0002-8703(03)00321-1.
29. Chung ES, Packer M, Lo KH, Fasanmade AA, Willerson JT; Anti-TNF Therapy Against Congestive Heart Failure Investigators. Randomized, doubleblind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-alpha, in patients with moderate-tosevere heart failure: results of the anti-TNF Therapy Against Congestive Heart Failure (ATTACH) trial. Circulation. 2003;107:3133-3140. doi: 10.1161/01.CIR.0000077913.60364.D2.
30. Deswal A, Bozkurt B, Seta Y, Parilti-Eiswirth S, Hayes FA, Blosch C, Mann DL. Safety and efficacy of a soluble P75 tumor necrosis factor receptor (Enbrel, etanercept) in patients with advanced heart failure. Circulation. 1999;99:3224-3226.
31. Mann DL, McMurray JJ, Packer M, Swedberg K, Borer JS, Colucci WS, Djian J, Drexler H, Feldman A, Kober L, Krum H, Liu P, Nieminen M, Tavazzi L, van Veldhuisen DJ, Waldenstrom A, Warren M, Westheim A, Zannad F, Fleming T. Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL). Circulation. 2004;109:1594-1602. doi: 10.1161/01. CIR.0000124490.27666.B2.
32. O'Donoghue ML, Glaser R, Cavender MA, Aylward PE, Bonaca MP, Budaj A, Davies RY, Dellborg M, Fox KA, Gutierrez JA, Hamm C, Kiss RG, Kovar F, Kuder JF, Im KA, Lepore JJ, Lopez-Sendon JL, Ophuis TO, Parkhomenko A, Shannon JB, Spinar J, Tanguay JF, Ruda M, Steg PG, Theroux P, Wiviott SD, Laws I, Sabatine MS, Morrow DA; LATITUDE-TIMI 60 Investigators. Effect of losmapimod on cardiovascular outcomes in patients hospitalized with acute myocardial infarction: a randomized clinical trial. JAMA. 2016;315:1591-1599. doi: 10.1001/jama.2016.3609.
33. Butler J, Hamo CE, Udelson JE, O'Connor C, Sabbah HN, Metra M, Shah SJ, Kitzman DW, Teerlink JR, Bernstein HS, Brooks G, Depre C, DeSouza MM, Dinh W, Donovan M, Frische-Danielson R, Frost RJ, Garza D, Gohring U-M, Hellawell J, Hsia J, Ishihara S, Kay-Mugford P, Koglin J, Kozinn M, Larson CJ, Mayo M, Gan L-M, Mugnier P, Mushonga S, Roessig L, Russo C, Salsali A, Satler C, Shi V, Ticho B, van der Laan M, Yancy C, Stockbridge N, Gheorghiade M. Reassessing phase II heart failure clinical trials. Circ Heart Fail. 2017;10:e003800.
34. Ridker PM, Thuren T, Zalewski A, Libby P. Interleukin-1β inhibition and the prevention of recurrent cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS). Am Heart 2011;162:597-605. doi: 10.1016/j.ahj.2011.06.012.
35. Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ; CANTOS Trial Group. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med. 2017;377:1119-1131. doi: 10.1056/NEJMoa1707914.