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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiopeutics Co., Ltd

About this trial

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).

Eligibility criteria

Qualifiers

Patients older than 18 years of age, of any gender/sex and race/ethnicity

most recent LVEF( by conventional imaging method<30% which was mwasured within 3 months prior randomization.

Nt-proBNP >1500 ng/L or BNP >300 ng/L at prior randomization

New York Heart Association (NYHA) functional class IIIb or IV, i.e., chronic dyspnoea or fatigue at rest or with minimal exertion for at least one month prior to consent.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Alprostadil

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators