Rationale and design of the comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode (PIONEER-HF) trial

American Heart Journal

Volumn 198, Issue , 2018, Pages 145-151

  Velazquez, Eric J ^a   Morrow, David A ^b   DeVore, Adam D ^a   Ambrosy, Andrew P ^a   Duffy, Carol I ^c   McCague, Kevin ^c   Hernandez, Adrian F ^a   Rocha, Ricardo A ^c   Braunwald, Eugene ^b  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; BIOLOGICAL MARKER; BRAIN NATRIURETIC PEPTIDE; ENALAPRIL; SACUBITRIL PLUS VALSARTAN; AMINOBUTYRIC ACID DERIVATIVE; PEPTIDE FRAGMENT; PRO-BRAIN NATRIURETIC PEPTIDE (1-76); TETRAZOLE DERIVATIVE;

ACUTE HEART FAILURE; ADULT; ARTICLE; CARDIAC PATIENT; CLINICAL OUTCOME; COHORT ANALYSIS; COMPARATIVE STUDY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HEART EJECTION FRACTION; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PHARMACEUTICAL CARE; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; PROTEIN URINE LEVEL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; URINE SAMPLING; AGED; CAUSE OF DEATH; CLINICAL TRIAL; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG DELIVERY SYSTEM; DRUG EFFECT; FORWARD HEART FAILURE; HEART FAILURE; MIDDLE AGED; MORTALITY; ORAL DRUG ADMINISTRATION; PATIENT SAFETY; PROGNOSIS; PROSPECTIVE STUDY; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; SURVIVAL RATE; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; AGED; AMINOBUTYRATES; CARDIAC OUTPUT, LOW; CAUSE OF DEATH; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG DELIVERY SYSTEMS; ENALAPRIL; FEMALE; HEART FAILURE; HUMANS; MALE; MIDDLE AGED; NATRIURETIC PEPTIDE, BRAIN; PATIENT SAFETY; PEPTIDE FRAGMENTS; PROGNOSIS; PROSPECTIVE STUDIES; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; SURVIVAL RATE; TETRAZOLES; TREATMENT OUTCOME;

EID: 85042182529     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2018.01.004     Document Type: Article

References (27)

1. Ambrosy, A.P., Fonarow, G.C., Butler, J., et al. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol 63 (2014), 1123–1133.
2. Braunwald, E., The war against heart failure: the Lancet lecture. Lancet 385 (2015), 812–824.
3. Writing Group M, Mozaffarian, D., Benjamin, E.J., et al. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation 133 (2016), e38–360.
4. Blecker, S., Paul, M., Taksler, G., et al. Heart failure–associated hospitalizations in the United States. J Am Coll Cardiol 61 (2013), 1259–1267.
5. Gheorghiade, M., Abraham, W.T., Albert, N.M., et al. Systolic blood pressure at admission, clinical characteristics, and outcomes in patients hospitalized with acute heart failure. JAMA 296 (2006), 2217–2226.
6. Vaduganathan, M., Greene, S.J., Ambrosy, A.P., et al. The disconnect between phase II and phase III trials of drugs for heart failure. Nat Rev Cardiol 10 (2013), 85–97.
7. Buggey, J., Mentz, R.J., DeVore, A.D., et al. Angiotensin receptor neprilysin inhibition in heart failure: mechanistic action and clinical impact. J Card Fail 21 (2015), 741–750.
8. McMurray, J.J., Packer, M., Desai, A.S., et al. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail 15 (2013), 1062–1073.
9. McMurray, J.J., Packer, M., Desai, A.S., et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med 371 (2014), 993–1004.
10. Yancy, C.W., Jessup, M., Bozkurt, B., et al. 2016 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines and the Heart Failure Society of America. J Am Coll Cardiol 68 (2016), 1476–1488.
11. Solomon, S.D., Zile, M., Pieske, B., et al. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet 380 (2012), 1387–1395.
12. Teerlink, J.R., Cotter, G., Davison, B.A., et al. Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet 381 (2013), 29–39.
13. Butler, J., Arbogast, P.G., Daugherty, J., et al. Outpatient utilization of angiotensin-converting enzyme inhibitors among heart failure patients after hospital discharge. J Am Coll Cardiol 43 (2004), 2036–2043.
14. Gattis, W.A., O'Connor, C.M., Gallup, D.S., et al. Predischarge initiation of carvedilol in patients hospitalized for decompensated heart failure: results of the Initiation Management Predischarge: Process for Assessment of Carvedilol Therapy in Heart Failure (IMPACT-HF) trial. J Am Coll Cardiol 43 (2004), 1534–1541.
15. McMurray, J.J., Packer, M., Desai, A.S., et al. Baseline characteristics and treatment of patients in prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial (PARADIGM-HF). Eur J Heart Fail 16 (2014), 817–825.
16. Desai, A.S., Solomon, S., Claggett, B., et al. Factors associated with noncompletion during the run-in period before randomization and influence on the estimated benefit of LCZ696 in the PARADIGM-HF Trial. Circ Heart Fail, 9, 2016, e002735.
17. Simpson, J., Jhund, P.S., Silva Cardoso, J., et al. Comparing LCZ696 with enalapril according to baseline risk using the MAGGIC and EMPHASIS-HF risk scores: an analysis of mortality and morbidity in PARADIGM-HF. J Am Coll Cardiol 66 (2015), 2059–2071.
18. Solomon, S.D., Claggett, B., Packer, M., et al. Efficacy of sacubitril/valsartan relative to a prior decompensation: the PARADIGM-HF trial. J Am Coll Cardiol HF 4 (2016), 816–822.
19. Desai, A.S., Claggett, B.L., Packer, M., et al. Influence of sacubitril/valsartan (LCZ696) on 30-day readmission after heart failure hospitalization. J Am Coll Cardiol 68 (2016), 241–248.
20. Bohm, M., Young, R., Jhund, P.S., et al. Systolic blood pressure, cardiovascular outcomes and efficacy and safety of sacubitril/valsartan (LCZ696) in patients with chronic heart failure and reduced ejection fraction: results from PARADIGM-HF. Eur Heart J 38 (2017), 1132–1143.
21. Packer, M., Love of angiotensin-converting enzyme inhibitors in the time of cholera. J Am Coll Cardiol HF 4:5 (2016), 403–408.
22. The CONSENSUS Trial Study Group, Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 316 (1987), 1429–1435.
23. The SOLVD Investigators, Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 325 (1991), 293–302.
24. Cohn, J.N., Tognoni G for the Valsartan Heart Failure Trial Investigators, Valsartan Heart Failure Trial I. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 345 (2001), 1667–1675.
25. Granger, C.B., McMurray, J.J., Yusuf, S., et al. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors: the CHARM-Alternative trial. Lancet 362 (2003), 772–776.
26. Zile, M.R., Claggett, B.L., Prescott, M.F., et al. Prognostic implications of changes in N-Terminal pro-B-Type natriuretic peptide in patients with heart failure. J Am Coll Cardiol 68 (2016), 2425–2436.
27. Desai, A.S., McMurray, J.J., Packer, M., et al. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur Heart J 36 (2015), 1990–1997.