Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- change in pulmonary capillary wedge pressure [ Time Frame: from baseline to 4 and 8 hours ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Drug: Comparator: Placebo
rolofylline placebo IV infusion over 4 hours.
rolofylline 30 mg IV infusion over 4 hours.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729222
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|