The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: A phase 2 double-blind randomised controlled trial

The Lancet

Volumn 380, Issue 9851, 2012, Pages 1387-1395

  Solomon, Scott D ^a   Zile, Michael ^b   Pieske, Burkert ^c   Voors, Adriaan ^d   Shah, Amil ^a   Kraigher Krainer, Elisabeth ^a   Shi, Victor ^e   Bransford, Toni ^e   Takeuchi, Madoka ^a   Gong, Jianjian ^e   Lefkowitz, Martin ^e   Packer, Milton ^f   McMurray, John J ^g  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^c UNIVERSITY OF GRAZ   (Austria)

^d UNIVERSITY OF GRONINGEN   (Netherlands)

^e NOVARTIS PHARMA AG   (Switzerland)

^f UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^g UNIVERSITY OF GLASGOW   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

3 (1 BIPHENYL 4 YLMETHYL 3 ETHOXYCARBONYL 1 BUTYLCARBAMOYL)PROPIONIC ACID PLUS VALSARTAN; AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; VALSARTAN;

ACUTE CORONARY SYNDROME; ADULT; AGED; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLOMERULUS FILTRATION RATE; HEART ARRHYTHMIA; HEART DISEASE; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERKALEMIA; HYPOTENSION; KIDNEY DISEASE; KIDNEY DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT OUTCOME;

EID: 84867745957     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(12)61227-6     Document Type: Article

References (41)

1. GC Fonarow, WG Stough, WT Abraham 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 50 2007 768 777
2. CS Lam, E Donal, E Kraigher-Krainer, RS Vasan Epidemiology and clinical course of heart failure with preserved ejection fraction Eur J Heart Fail 13 2011 18 28
3. RS Bhatia, JV Tu, DS Lee et al. Outcome of heart failure with preserved ejection fraction in a population-based study N Engl J Med 355 2006 260 269
4. TE Owan, DO Hodge, RM Herges, SJ Jacobsen, VL Roger, MM Redfield Trends in prevalence and outcome of heart failure with preserved ejection fraction N Engl J Med 355 2006 251 259
5. SD Solomon, N Anavekar, H Skali Candesartan in Heart Failure Reduction in Mortality (CHARM) Investigators Influence of ejection fraction on cardiovascular outcomes in a broad spectrum of heart failure patients Circulation 112 2005 3738 3744
6. GP Aurigemma, WH Gaasch Clinical practice. Diastolic heart failure N Engl J Med 351 2004 1097 1105
7. MR Zile, CF Baicu, WH Gaasch Diastolic heart failure - abnormalities in active relaxation and passive stiffness of the left ventricle N Engl J Med 350 2004 1953 1959
8. BA Borlaug, WJ Paulus Heart failure with preserved ejection fraction: pathophysiology, diagnosis, and treatment Eur Heart J 32 2011 670 679
9. L Tartière-Kesri, JM Tartière, D Logeart, F Beauvais, A Cohen Solal Increased proximal arterial stiffness and cardiac response with moderate exercise in patients with heart failure and preserved ejection fraction J Am Coll Cardiol 59 2012 455 461
10. G Yip, M Wang, Y Zhang et al. Left ventricular long axis function in diastolic heart failure is reduced in both diastole and systole: time for a redefintion? Heart 87 2002 121 125
11. CM Yu, H Lin, H Yang, SL Kong, Q Zhang, SW Lee Progression of systolic abnormalities in patients with "isolated" diastolic heart failure and diastolic dysfunction Circulation 105 2002 1201 1995
12. YT Tan, F Wenzelburger, E Lee et al. The pathophysiology of heart failure with normal ejection fraction: exercise echocardiography reveals complex abnormalities of both systolic and diastolic ventricular function involving torsion, untwist, and longitudinal motion J Am Coll Cardiol 54 2009 36 46
13. PM McKie, JA Schirger, LC Costello-Boerrigter et al. Impaired natriuretic and renal endocrine response to acute volume expansion in pre-clinical systolic and diastolic dysfunction J Am Coll Cardiol 58 2011 2095 2103
14. WS Aronow, C Ahn, I Kronzon Effect of propranolol versus no propranolol on total mortality plus nonfatal myocardial infarction in older patients with prior myocardial infarction, congestive heart failure, and left ventricular ejection fraction > or = 40 treated with diuretics plus angiotensin- converting enzyme inhibitors Am J Cardiol 80 1997 207 209
15. JF Setaro, BL Zaret, DS Schulman, HR Black, R Soufer Usefulness of verapamil for congestive heart failure associated with abnormal left ventricular diastolic filling and normal left ventricular systolic performance Am J Cardiol 66 1990 981 986
16. JG Cleland, M Tendera, J Adamus, N Freemantle, L Polonski, J Taylor PEP-CHF Investigators The perindopril in elderly people with chronic heart failure (PEP-CHF) study Eur Heart J 27 2006 2338 2345
17. S Yusuf, MA Pfeffer, K Swedberg for the CHARM Investigators and Committees Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial Lancet 362 2003 777 781
18. BM Massie, PE Carson, JJ McMurray I-PRESERVE Investigators Irbesartan in patients with heart failure and preserved ejection fraction N Engl J Med 359 2008 2456 2467
19. RV Shah, RS Desai, MM Givertz The effect of renin-angiotensin system inhibitors on mortality and heart failure hospitalizations in patients with heart failure and preserved ejection fraction: a systematic review and meta-analysis J Card Fail 16 2010 260 267
20. J Gu, A Noe, P Chandra et al. Pharmacokinetics and pharmacodynamics of LCZ696, a novel dual-acting angiotensin receptor-neprilysin inhibitor (ARNi) J Clin Pharmacol 50 2010 401 414
21. A Martinez-Rumayor, AM Richard, JC Burnett, JC Januzzi Biology of the natriuretic peptides Am J Cardiol 101 suppl 2008 3A 8A
22. LR Potter, S Abbey-Horsch, DM Dickey Natriuretic peptides, their receptors and cyclic guanosine monopohosphate-dependent signaling functions Endocr Rev 27 2006 47 72
23. DG Gardner, S Chen, DJ Glenn et al. Molecular biology of the natriuretic peptide system: implications for physiology and hypertension Hypertension 49 2007 419 426
24. AM Richards, GA Wittert, IG Crozier et al. Chronic inhibition of endopeptidase 24.11 in essential hypertension: evidence for enhanced atrial natriuretic peptide and angiotensin II J Hypertens 11 1993 407 416
25. RM Fryer, J Segreti, PN Banfor et al. Effect of bradykinin metabolism inhibitors on evoked hypotension in rats: rank efficacy of enzymes associated with bradykinin-mediated angioedema Br J Pharmacol 153 2008 947 955
26. JB Kostis, M Packer, HR Black, R Schmieder, D Henry, E Levy Omapatrilat and enalapril in patients with hypertension: the Omapatrilat Cardiovascular Treatment vs. Enalapril (OCTAVE) trial Am J Hypertens 17 2004 103 111
27. LM Ruilope, A Dukat, M Böhm, Y Lacourcière, J Gong, MP Lefkowitz 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 375 2010 1255 1266
28. CP Green, CB Porter, DR Bresnahan, JA Spertus Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure J Am Coll Cardiol 35 2000 1245 1255
29. RM Lang, M Bierig, RB Devereux 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 18 2005 1440 1463
30. SD Solomon, R Janardhanan, A Verma for the Valsartan In Diastolic Dysfunction (VALIDD) Investigators Effect of angiotensin receptor blockade and antihypertensive drugs on diastolic function in patients with hypertension and diastolic dysfunction: a randomised trial Lancet 369 2007 2079 2087
31. M Packer Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure J Card Fail 7 2001 176 182
32. JJ McMurray, S Adamopoulos, SD Anker et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC Eur Heart J 33 2012 1787 1847
33. LB Daniels, AS Maisel Natriuretic peptides J Am Coll Cardiol 50 2007 2357 2368
34. S Masson, R Latini, IS Anand Val-HeFT Investigators Prognostic value of changes in N-terminal pro-brain natriuretic peptide in Val-HeFT (Valsartan Heart Failure Trial) J Am Coll Cardiol 52 2008 997 1003
35. JG Cleland, J Taylor, M Tendera Prognosis in heart failure with a normal ejection fraction N Engl J Med 357 2007 829 830
36. M Komajda, PE Carson, S Hetzel et al. Factors associated with outcome in heart failure with preserved ejection fraction: findings from the Irbesartan in Heart Failure with Preserved Ejection Fraction Study (I-PRESERVE) Circ Heart Fail 4 2011 27 35
37. SL Chow, SA O'Barr, J Peng et al. Renal function and neurohormonal changes following intravenous infusions of nitroglycerin versus nesiritide in patients with acute decompensated heart failure J Card Fail 17 2011 181 187
38. DL Vesely, MA Douglass, JR Dietz et al. Negative feedback of atrial natriuretic peptides J Clin Endocrinol Metab 78 1994 1128 1134
39. E Giannetta, AM Isidori, N Galea et al. Chronic inhibition of cGMP phosphodiesterase 5A improves diabetic cardiomyopathy a randomized, controlled clinical trial using magnetic resonance imaging with myocardial tagging Circulation 125 2012 2323 2333
40. A Brenyo, MS Link, A Barsheshet et al. Cardiac resynchronization therapy reduces left atrial volume and the risk of atrial tachyarrhythmias in MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) J Am Coll Cardiol 58 2011 1682 1689
41. MR Zile, JS Gottdiener, SJ Hetzel I-PRESERVE Investigators Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction Circulation 124 2011 2491 2501