Status:
NOT_YET_RECRUITING
ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure
Lead Sponsor:
Biopeutics Co., Ltd
Conditions:
End Stage Cardiac Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
We anticipate needing to screen ca. 600 patients in order to ransomize our target sample size of 400 participants. Participants will be randomozed 1:1to receive either alprostadil or placebo. Based on...
Eligibility Criteria
Inclusion
- Patients older than 18 years of age, of any gender/sex and race/ethnicity
- Patients with a diagnosis of advanced HFrEF as evidenced by (all must apply):
- 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.
- Renal dysfunction reflected by a glomerular filtration rate (GFR) \<60 mL/min approximated by the Modification of Diet in Renal Disease formula.
- A total symptom score of KCCQ of \<70measure within 24 hours of randomization
- Patients on all appropriate recommended HF therapy.
- Patient should not be receiving continuous or planned intermittent intravenous infusions with a positive inotropic or vasodilator drug in a non-hospitalized setting
- Patients should not be considered as candidates for heart transplantation or LVAD for at least 6 months from randomization according to the opinion of the treating physician.
- Women of childbearing potential (i.e., who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must commit either to abstain continuously from heterosexual sexual contact or to use at least one "highly effective" method of birth control (e.g., intrauterine device \[IUD\], hormonal contraception, tubal ligation, or partner's vasectomy) or two "effective" methods (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to screening and throughout study participation.
- Note: As alprostadil is not genotoxic and female sexual partners of male study participants are not likely to have substantial exposure via semen, there are no contraception requirements for men.
- Patients must be willing and able to give written informed consent, including local data privacy consents, as required
Exclusion
Key Trial Info
Start Date :
October 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00610051
Start Date
October 1 2026
End Date
December 1 2030
Last Update
December 15 2025
Active Locations (1)
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1
Medical university Vienna
Vienna, Austria