Journal of Cardiac Failure
Volume 16, Issue 1 , Pages 25-35 , January 2010

Design and Rationale of the PROTECT Study: A Placebo-controlled Randomized Study of the Selective A1 Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized With Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function

  • Beth Davison Weatherley, PhD

      Affiliations

    • Momentum Research, Inc., Durham, NC
    • ,
  • Gad Cotter, MD

      Affiliations

    • Momentum Research, Inc., Durham, NC
    • ,
  • Howard C. Dittrich, MD

      Affiliations

    • NovaCardia, Inc., San Diego, CA
    • Corresponding Author InformationReprint requests: Howard C Dittrich, MD, 12750 High Bluff Drive, Suite 300, San Diego, CA 92130.
    • ,
  • Paul DeLucca, PhD

      Affiliations

    • Merck Research Laboratories, Rahway, NJ
    • ,
  • George A. Mansoor, MD

      Affiliations

    • Merck Research Laboratories, Rahway, NJ
    • ,
  • Daniel M. Bloomfield, MD

      Affiliations

    • Merck Research Laboratories, Rahway, NJ
    • ,
  • Piotr Ponikowski, MD

      Affiliations

    • Klinika Kardiologii, WrocLaw, Poland
    • ,
  • Christopher M. O'Connor, MD

      Affiliations

    • Duke University Medical Center, Durham, NC
    • ,
  • Marco Metra, MD

      Affiliations

    • University of Brescia, Brescia, Italy
    • ,
  • Barry M. Massie, MD

      Affiliations

    • University of California, San Francisco, CA
    • ,
  • PROTECT Steering Committee, Investigators, and Coordinators

Received 22 July 2009 ,Revised 12 October 2009 ,Accepted 27 October 2009.

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 All decisions regarding this manuscript were made by a guest editor.

 Funded by Merck & Co., Inc., Whitehouse Station, NJ.

 Author Disclosures and Contributions

 Howard C. Dittrich, MD, employee of NovaCardia, Inc, a wholly owned subsidiary of Merck & Co and consultant to Merck & Co (H.C.D.); Piotr Ponikowski, MD: Investigator and Executive Committee member (P.P.); Beth Davison Weatherley PhD: Employee of Momentum Research, Inc, a vendor to Merck & Co (B.D.W.); Marco Metra, MD: Investigator and Executive Committee member (M.M.); John R. Teerlink MD: Chair, Clinical Events Committee (J.R.T.); Gad Cotter MD: Employee of Momentum Research, Inc, a vendor to Merck & Co (G.C.); Paul DeLucca PhD: Employee of Merck & Co (P.D.); George A. Mansoor MD: Employee of Merck & Co (G.A.M.); Daniel M. Bloomfield, MD: Employee of Merck & Co (D.M.B.); Christopher M. O'Connor, MD: Co-Principal Investigator, Consultant to Merck & Co (C.M.O'C.); Barry M. Massie, MD: Co-Principal Investigator, Consultant to Merck & Co (B.M.M.).

 The manuscript was primarily drafted by Drs Dittrich, Ponikowski, Bloomfield, and Massie, with substantial contributions from Drs Weatherley and DeLucca regarding the statistical and analysis plan. The other listed authors reviewed and commented on the manuscript at several stages and approved the final submitted version. No unlisted individuals contributed to the writing of this manuscript.

PII: S1071-9164(09)01146-4

doi: 10.1016/j.cardfail.2009.10.025

Journal of Cardiac Failure
Volume 16, Issue 1 , Pages 25-35 , January 2010

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