ConditionsEnd Stage Cardiac FailureHFrEF - Heart Failure With Reduced Ejection FractionNYHF Class III-IV
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 groupsSponsors and collaborators
Source ClinicalTrials.gov