Journal of Cardiac Failure
Volume 14, Issue 8 , Pages 631-640, October 2008

The PROTECT Pilot Study: A Randomized, Placebo-Controlled, Dose-Finding Study of the Adenosine A1 Receptor Antagonist Rolofylline in Patients With Acute Heart Failure and Renal Impairment

  • Gad Cotter, MD

      Affiliations

    • Momentum Research, Inc, Durham, North Carolina
    • Drs Cotter and Dittrich contributed equally to the study.
    • ,
  • Howard C. Dittrich, MD

      Affiliations

    • NovaCardia Inc, San Diego, California
    • Drs Cotter and Dittrich contributed equally to the study.
    • ,
  • Beth Davison Weatherley, PhD

      Affiliations

    • Momentum Research, Inc, Durham, North Carolina
    • ,
  • Daniel M. Bloomfield, MD

      Affiliations

    • Merck Research Laboratories, Rahway, New Jersey
    • ,
  • Christopher M. O'connor, MD

      Affiliations

    • Duke University Medical Center, Durham, North Carolina
    • ,
  • Marco Metra, MD

      Affiliations

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

      Affiliations

    • University of California, San Francisco, San Francisco, California
    • Corresponding Author InformationReprint requests: Barry M. Massie, MD, University of California San Francisco, San Francisco VA Medical Center, Department of Cardiology, 111C, 4150 Clement Street, San Francisco, CA 94121-1545.
    • ,
  • for the PROTECT Steering Committee, Investigators, and Coordinators

Received 15 August 2008; received in revised form 28 August 2008; accepted 29 August 2008. published online 16 September 2008.

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 All decisions regarding this manuscript were made by a Guest Editor.

 This study was funded by NovaCardia, Inc. As of September 2007, NovaCardia is a wholly owned subsidiary of Merck & Co, Inc. Drs Cotter, Massie, Metra, and O'Connor are members of the PROTECT Steering Committee and receive grant support from Merck and NovaCardia. Dr Bloomfield is an employee of Merck. Drs Cotter and Weatherley are employees of Momentum Research Inc. and are consultants to Merck. Dr Dittrich was an employee of NovaCardia and is now a consultant to Merck. Dr Metra has occasionally received honoraria and reimbursement for travel expenses from Actelion, Corthera, Merck, and Servier. Dr Massie receives consulting fees from BAS Medical, Duke Clinical Research Institute, Merck, Niles Therapeutics, and Scios.

 The PROTECT study is registered on www.clinicaltrials.gov as NCT00328692 (PROTECT-1) and NCT00354458 (PROTECT-2).

PII: S1071-9164(08)00980-9

doi:10.1016/j.cardfail.2008.08.010

Journal of Cardiac Failure
Volume 14, Issue 8 , Pages 631-640, October 2008

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