Alprostadil Continuous Intravenous Infusion in Bridging Cardiac Transplant in Severe Heart Failure Patients
This is a multicenter, double blind, placebo-controlled, randomized, parallel group study that compares Alprostadil given in a low, fixed-dose continuous infusion and placebo. The difference between the two groups for the primary endpoints will be compared after 24 weeks (Outpatient Double-Blind Treatment Phase). Thereafter, patients will continue on blinded treatment and observation to all continued assessment of survival and cardiac-specific mortality (Follow-Up Phase). It is planned that approximately 550 patients with advanced heart failure be randomized (see Inclusion and Exclusion Criteria
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase 3 Study of Alprostadil Continuous Intravenous Infusion in Bridging Cardiac Transplant in Severe Heart Failure Patients|
- To evaluate the efficacy and tolerability given in a continuous fixed low dose intravenous infusion in bridging patients with severe heart failure during waiting time for cardiac transplantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To assess both overall survival and cardiovascular-specific mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To assess transplantation success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To evaluate the effect of Alprostadil on Nt-proBNP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2
compare the efficacy of Alprostadil with placebo
central venous access continuous delivery with 2.5ng/kg/min
Other Name: Papeilin
During the Screening Phase, informed consent will be obtained and information to establish eligibility for transplant and all other inclusion and exclusion criteria will be assessed. The screening activities may be performed on an outpatient basis in stable patients or as an inpatient in unstable patients who are already hospitalized.
Throughout the study, patients will be maintained medically in accordance with the national Guidelines for heart failure, which are mostly based on the European Guidelines for Heart Failure (2005) and the American Guidelines for Heart Failure, The primary assessment of efficacy is based on the number of days that the patient is hospitalized or is deceased during the 24 weeks following the day of randomization, As elective transplantation is biased by donor availability, observation period in those cases will be counted until ELECTIVE heart transplantation. Additional surrogate measures of efficacy will include monthly assessments of Nt-proBNP, patient assessment of dyspnoea, Minnesota Living with Heart Failure Questionnaire, NYHA classification, and use of beta1-blocker therapy.
Study Population It is planned that a sufficient number of patients will be screened to enroll 500 patients (250 patients per treatment group). Compliance with the inclusion and exclusion criteria outlined below must be established prior to randomization to double-blind therapy.