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Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: Placebo
rolofylline
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg

Exclusion Criteria:

  • Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Placebo

    rolofylline

    Outcomes

    Primary Outcome Measures

    change in pulmonary capillary wedge pressure

    Secondary Outcome Measures

    Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure

    Full Information

    First Posted
    August 5, 2008
    Last Updated
    October 19, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    NovaCardia, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00729222
    Brief Title
    Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)
    Official Title
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    NovaCardia, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    rolofylline
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    rolofylline placebo IV infusion over 4 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    rolofylline
    Intervention Description
    rolofylline 30 mg IV infusion over 4 hours.
    Primary Outcome Measure Information:
    Title
    change in pulmonary capillary wedge pressure
    Time Frame
    from baseline to 4 and 8 hours
    Secondary Outcome Measure Information:
    Title
    Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure
    Time Frame
    from baseline to 4 and 8 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg Exclusion Criteria: Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20823097
    Citation
    Ponikowski P, Mitrovic V, O'Connor CM, Dittrich H, Cotter G, Massie BM, Givertz MM, Chen E, Murray M, Weatherley BD, Fujita KP, Metra M. Haemodynamic effects of rolofylline in the treatment of patients with heart failure and impaired renal function. Eur J Heart Fail. 2010 Nov;12(11):1238-46. doi: 10.1093/eurjhf/hfq137. Epub 2010 Sep 7.
    Results Reference
    result

    Learn more about this trial

    Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)

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