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
About this trial
This is an interventional treatment trial for Heart Failure
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
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
NCT ID
NCT00729222
First Posted
August 5, 2008
Last Updated
October 19, 2015
Sponsor
Merck Sharp & Dohme LLC
Collaborators
NovaCardia, Inc.
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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