Journal of Cardiac Failure
Volume 13, Issue 9 , Pages 715-721 , November 2007

Rationale, Design, and Methods for a Pivotal Randomized Clinical Trial of Continuous Aortic Flow Augmentation in Patients With Exacerbation of Heart Failure: The MOMENTUM Trial

  • Barry Greenberg, MD

      Affiliations

    • University of California, San Diego, San Diego, California
    • ,
  • Barbara Czerska, MD

      Affiliations

    • Henry Ford Heart and Vascular Institute, Detroit, Michigan
    • ,
  • William T. Abraham, MD

      Affiliations

    • The Ohio State University, Columbus, Ohio
    • ,
  • James D. Neaton, PhD

      Affiliations

    • University of Minnesota, Minneapolis, Minnesota
    • ,
  • Reynolds M. Delgado, MD

      Affiliations

    • Texas Heart Institute, Houston, Texas
    • ,
  • Paul Mather, MD

      Affiliations

    • Jefferson University, Philadelphia, Pennsylvania
    • ,
  • Robert Bourge, MD

      Affiliations

    • University of Alabama, Birmingham, Alabama
    • ,
  • Irene C. Parker, RN

      Affiliations

    • Orqis Medical, Lake Forest, California
    • ,
  • Marvin A. Konstam, MD

      Affiliations

    • Tufts-New England Medical Center, Boston, Massachusetts
    • Corresponding Author InformationReprint requests: Marvin A. Konstam, MD, Box 108, Tufts-New England Medical Center, 750 Washington St., Boston, MA 02111.
    • ,
  • on behalf of the MOMENTUM Investigators and Coordinators

Received 24 April 2006 ,Revised 15 June 2007 ,Accepted 18 June 2007.

References 

  1. American Heart Association 2004. Heart disease and stroke statistics—2004 update. Dallas, TX: American Heart Association. Available at: www.americanheart.org. Accessed July 28, 2004.
  2. Krumholz HM, Parent EM, Tu N, Vaccarino V, Wang Y, Radford MJ, et al. Readmission after hospitalization for congestive heart failure among Medicare beneficiaries. Arch Intern Med. 1997;157:99–104
  3. Jain P, Massie BM, Gattis WA, Klein L, Gheorghiade M. Current medical treatment for the exacerbation of chronic heart failure resulting in hospitalization. Am Heart J. 2003;145:S3–S17
  4. Frazier OH, Rose EA, Oz MC, Dembitsky W, McCarthy P, Radovancevic B, et al. HeartMate Investigators. Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation. J Thorac Cardiovasc Surg. 2001;122:1186–1195
  5. Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001;345:1435–1443
  6. Haithcock BE, Morita H, Fanous NH, Suzuki G, Sabbah HN. Hemodynamic Unloading of the failing left ventricle using an arterial-to-arterial extracorporeal flow circuit. Ann Thorac Surg. 2004;77:158–163
  7. Gharib M, Beizaie M. Correlation between negative near-wall shear stress in human aorta and various stages of congestive heart failure. Ann Biomed Eng. 2003;3:678–685
  8. Lu X, Kassab GS. Nitric oxide is significantly reduced in ex-vivo porcine arteries during reverse flow because of increased superoxide production. J Physiol. 2004;561(Pt 2):575–582
  9. Konstam MA, Czerska B, Böhm M, Oren RM, Sadowski J, Khanal S, et al. Continuous aortic flow augmentation: hemodynamic and renal responses to a novel percutaneous intervention in patients with decompensated heart failure. Circulation. 2005;112:3107–3114
  10. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31–41
  11. Mahon NG, Blackstone EH, Francis GS, Starling RC, Young JB, Lauer MS. The prognostic value of estimated creatinine clearance alongside functional capacity in ambulatory patients with chronic congestive heart failure. J Am Coll Cardiol. 2002;40:1106–1113
  12. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika. 1988;75:800–802
  13. Gould AL. Sample size re-estimation: recent developments and practical considerations. Stat Med. 2001;20:2625–2643
  14. Yamamoto K, Burnett JC, Jougasaki M, Nishimura RA, Bailey KR, Saito Y, et al. Superiority of brain natriuretic peptide as a hormonal marker of ventricular systolic and diastolic dysfunction and ventricular hypertrophy. Hypertension. 1996;28:988–994
  15. Redfield MM, Rodeheffer RJ, Jacobsen SJ, Mahoney DW, Bailey KR, Burnett JC. Plasma brain natriuretic peptide concentration: impact of age and gender. J Am Coll Cardiol. 2002;40:976–982
  16. Erlandsen EJ, Randers E, Kristensen JH. Evaluation of the Dade Behring N Latex Cystatin C Assay on the Dade Behring Nephelometer II System. Scand J Clin Lab Invest. 1999;59:1–8
  17. Moshage H, Kok B, Huizenga J, Jansen L. Nitrite and nitrate determinations in plasma: a critical evaluation. Clin Chem. 1995;6:892–896
  18. Cooper HA, Dries DL, Davis CE, Shen YL, Domanski MJ. Diuretics and risk of arrhythmic death in patients with left ventricular dysfunction. Circulation. 1999;100:1311–1315
  19. Domanski M, Norman J, Pitt B, Haigney M, Hanlon S, Peyster E. Diuretic use, progressive heart failure, and death in patients in the Studies of Left Ventricular Dysfunction (SOLVD). J Am Coll Cardiol. 2003;42:705–708
  20. Cotter G, Metzkor E, Kaluski E, Faigenberg Z, Miller R, Simovitz A, et al. Randomized trial of high-dose isosorbide dinitrate plus low-dose furosemide versus high-dose furosemide plus low-dose isosorbide dinitrate in severe pulmonary edema. Lancet. 1998;351:389–393
  21. Packer M, Carver JR, Rodeheffer RJ, Ivanhoe RJ, DiBianco R, Zeldis SM, et al. Effect of oral milrinone on mortality in severe chronic heart failure. The PROMISE Study Research Group. N Engl J Med. 1991;325:1468–1475
  22. Cuffe MS, Califf RM, Adams KF, Benza R, Bourge R, Colucci WS, et al. Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) Investigators. Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial. JAMA. 2002;287:1541–1547
  23. O'Connor CM, Gattis WA, Uretsky BF, Adams KF, McNulty SE, Grossman SH, et al. Continuous intravenous dobutamine is associated with an increased risk of death in patients with advanced heart failure: insights from the Flora International Randomized Survival Trial (FIRST). Am Heart J. 1999;138:78–86
  24. Bouvy ML, Heerdink ER, De Bruin ML, Herings RM, Leufkens HG, Hoes AW. Use of sympathomimetic drugs leads to increased risk of hospitalization for arrhythmias in patients with congestive heart failure. Arch Intern Med. 2000;160:2477–2480
  25. Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, et al. for the MIRACLE Study Group Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002;346:1845–1853
  26. Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, et al. for the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140–2150
  27. Bart BA, Boyle A, Bank AJ, Anand I, Olivari MT, Kraemer MD, et al. Ultrafiltration versus usual care for hospitalized patients with heart failure: the Relief for Acutely Fluid-Overloaded Patients With Decompensated Congestive Heart Failure (RAPID-CHF) trial. J Am Coll Cardiol. 2005;46:2043–2046
  28. Al-Ahmad A, Rand WM, Manjunath G, Konstam MA, Salem DN, Levey AS, et al. Reduced kidney function and anemia as risk factors for mortality in patients with left ventricular dysfunction. J Am Coll Cardiol. 2001;38:955–962
  29. Weinfeld MS, Chertow GM, Stevenson LW. Aggravated renal dysfunction during intensive therapy for advanced chronic heart failure. Am Heart J. 1999;138:285–290
  30. Aronson D, Mittleman MA, Burger AJ. Elevated blood urea nitrogen level as a predictor of mortality in patients admitted for decompensated heart failure. Am J Med. 2004;116:466–473
  31. Forman DE, Butler J, Wang Y, Abraham WT, O'Connor CM, Gottlieb SS, et al. Incidence, predictors at admission, and impact of worsening renal function among patients hospitalized with heart failure. J Am Coll Cardiol. 2004;43:61–67
  32. Shah MR, Stinnett SS, McNulty SE, Gheorghiade M, Zannad F, Uretsky B, et al. Hemodynamics as surrogate end points for survival in advanced heart failure: an analysis from FIRST. Am Heart J. 2001;141:908–914
  33. Fonarow GC. The treatment targets in acute decompensated heart failure. Rev Cardiovasc Med. 2001;2(Suppl 2):S7–S12

 The study was funded by Orqis Medical Inc., Lake Forest, California.

PII: S1071-9164(07)00943-8

doi: 10.1016/j.cardfail.2007.06.728

Journal of Cardiac Failure
Volume 13, Issue 9 , Pages 715-721 , November 2007

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