Overview

Alprostadil Continuous Intravenous Infusion in Bridging Cardiac Transplant in Severe Heart Failure Patients

Status:
Not yet recruiting

Trial end date:
2024-12-01

Target enrollment:

Participant gender:

Summary

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

Phase:

Phase 3

Details

Lead Sponsor:

Biopeutics Co., Ltd

Treatments:

Alprostadil