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).
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.
None
Parallel
Alprostadil
Drugcentral venous access continuous delivery with 500mcg/48 hours in active arm
Time to all-cause mortality (defined as death, heart transplant, LVAD placement, mechanical circulatory support, or HF event(* hospitalization for HF or unplanned intravenous therapy for HF, ie diurectics, inotropes, vassopressors, or vasodilators.)
To access the effect of continue 6-months ALP-1infusion at a fixed dose of at 500mcg/48 hr. in patinets with advanced heart failure with reduced ejection fraction(HrEF) compare to placebo.
Secondary Efficacy and Safety Endpoints
. physcians review NYHA HF functional classification
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This trial is not recruiting at the moment. You can still explore other options:
