MedTrace Logo

ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure

NCT00610051 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-12-15

No results posted yet for this study

Summary

This is a global multicenter, doubleblind, placebo-controlled, randomized, parallel-group study that compares ALP-1 given in a continuous infusion ( compared to placebo), 250mcg/day on majore outcomes up to 6 months after randomization in participants with advanced HF with reduced ejection fraction(HFrEF).

Conditions

  • End Stage Cardiac Failure
  • HFrEF - Heart Failure With Reduced Ejection Fraction
  • NYHF Class III-IV

Interventions

DRUG

Alprostadil

central venous access continuous delivery with 500mcg/48 hours in active arm

Sponsors & Collaborators

  • Biopeutics Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Martin Huelsmann, MD · Medical university Vienna, Department of Cardiology

  • Noemi Pavo, MD PhD · Medical University Vienna, department of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-11-30
Completion
2030-12-31
FDA Drug
Yes

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00610051 on ClinicalTrials.gov