Rationale and design of the OPTIME CHF trial: Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure

Michael S. Cuffe, Robert M. Califf, Kirkwood F. Adams, Robert C. Bourge, Wilson Colucci, Barry Massie, Christopher M. O'Connor, Ileana L. Pina, Rebecca Quigg, Marc Silver, Lee Ann Robinson, Jeffrey D. Leimberger, Mihai Gheorghiade

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Background: The optimal management of an acute exacerbation of chronic heart failure (CHF) is uncertain. There is little randomized evidence available to support the various treatment strategies for patients hospitalized with an exacerbation of CHF. Inotropic agents may produce beneficial hemodynamic effects, and although they are currently used in these patients, their effect on clinical response and impact on clinical outcome is unclear. We present a unique and simple study designed to determine whether a treatment strategy for CHF exacerbations that includes an intravenous agent with inotropic properties can reduce hospital length of stay and lead to improved patient outcome. Methods: The OPTIME CHF (Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure) trial is an ongoing multicenter, randomized, placebo-controlled trial of a treatment strategy for patients with acute exacerbations of CHF. The design of this study provides a novel approach to the evaluation of treatment strategies in the care of this population. The OPTIME CHF design uses early initiation of intravenous milrinone as both an adjunct to the best the medical therapy and to facilitate optimal dosing of standard oral therapy for heart failure. Patients with known systolic heart failure requiring hospital admission for a CHF exacerbation are randomly assigned within 48 hours of admission to receive a 48-hour infusion of either intravenous milrinone or placebo. The primary end point of this design is a reduction in the total hospital days for cardiovascular events within 60 days after therapy. Enrollment of 1000 patients began July 7, 1997, at 80 US centers and is projected to conclude in late 1999.

Original languageEnglish (US)
Pages (from-to)15-22
Number of pages8
JournalAmerican Heart Journal
Volume139
Issue number1 I
StatePublished - 2000
Externally publishedYes

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Milrinone
Heart Failure
Therapeutics
Length of Stay
Placebos
Systolic Heart Failure
Intravenous Infusions
Randomized Controlled Trials
Hemodynamics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Cuffe, M. S., Califf, R. M., Adams, K. F., Bourge, R. C., Colucci, W., Massie, B., ... Gheorghiade, M. (2000). Rationale and design of the OPTIME CHF trial: Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure. American Heart Journal, 139(1 I), 15-22.

Rationale and design of the OPTIME CHF trial : Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure. / Cuffe, Michael S.; Califf, Robert M.; Adams, Kirkwood F.; Bourge, Robert C.; Colucci, Wilson; Massie, Barry; O'Connor, Christopher M.; Pina, Ileana L.; Quigg, Rebecca; Silver, Marc; Robinson, Lee Ann; Leimberger, Jeffrey D.; Gheorghiade, Mihai.

In: American Heart Journal, Vol. 139, No. 1 I, 2000, p. 15-22.

Research output: Contribution to journalArticle

Cuffe, MS, Califf, RM, Adams, KF, Bourge, RC, Colucci, W, Massie, B, O'Connor, CM, Pina, IL, Quigg, R, Silver, M, Robinson, LA, Leimberger, JD & Gheorghiade, M 2000, 'Rationale and design of the OPTIME CHF trial: Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure', American Heart Journal, vol. 139, no. 1 I, pp. 15-22.
Cuffe, Michael S. ; Califf, Robert M. ; Adams, Kirkwood F. ; Bourge, Robert C. ; Colucci, Wilson ; Massie, Barry ; O'Connor, Christopher M. ; Pina, Ileana L. ; Quigg, Rebecca ; Silver, Marc ; Robinson, Lee Ann ; Leimberger, Jeffrey D. ; Gheorghiade, Mihai. / Rationale and design of the OPTIME CHF trial : Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure. In: American Heart Journal. 2000 ; Vol. 139, No. 1 I. pp. 15-22.
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