Alprostadil Continuous Intravenous Infusion in Bridging Cardiac Transplant in Severe Heart Failure Patients

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, double blind, placebo-controlled, randomized, parallel group study that compares Alprostadil given in a low, fixed-dose continuous infusion and placebo. The difference between the two groups for the primary endpoints will be compared after 24 weeks (Outpatient Double-Blind Treatment Phase). Thereafter, patients will continue on blinded treatment and observation to all continued assessment of survival and cardiac-specific mortality (Follow-Up Phase). It is planned that approximately 550 patients with advanced heart failure be randomized (see Inclusion and Exclusion Criteria

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biopeutics Co., Ltd
• Treatments: Alprostadil

Criteria

Inclusion Criteria:

1. Patients of either gender and of any race/ethnicity who are between 18 and 70 years of age inclusive

2. Patients in advanced cardiac heart failure in New York Heart Association (NYHA) functional class IIIb or IV

3. Eligible for heart transplant according to the ISHLT guidelines ; it is not necessary that the patient already be listed at time of screening

4. Patients with secondary pulmonary hypertension (pulmonary artery pressure [PAP] > 50 mmHg on echocardiography or pulmonary resistance on right heart catheterization), who are usually excluded from transplantation under conventional conditions, are eligible for inclusion in this study

5. Patients with left ventricular ejection fraction (LVEF) ≤ 35% by any acceptable method (e.g., echocardiography, radionuclideventriculography, or ventriculography) assessed within the 3 months prior to randomization

6. Nt-proBNP > 2000 pg/mL

7. 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

8. Patients must be willing and able to give written informed consent. Where required, a HIPAA and/or state privacy consent must also be signed

Exclusion Criteria:

1. Patients urgently requiring transplantation (in the United States, United Network for Organ Sharing [UNOS] Status 1A; in the E.U., urgent request mode at EUROTRANSPLANT)

2. Patients or their relatives/caregivers who are determined by the training nurse not to be capable of correctly using the pump delivery system and handling the study drug

3. Patients presenting with unstable angina, aortic stenosis, pulmonary edema, severe chronic obstructive pulmonary disease, or acute gastric or duodenal ulcers

4. Patients with a history of myocardial infarction or stroke within 6 months of screening

5. Patients with systolic blood pressure < 90 mmHg under euvolemic or hypervolemic conditions

6. Patients with significant chronic renal dysfunction (serum creatinine ≥2.5 mg/dL)

7. Female patients who are pregnant or nursing

8. Patients who have any concomitant illness or other finding that, in the opinion of the Investigator, would confound the interpretation of the study results or place the patient at unacceptable risk if the patient were to participate in the study

9. Patients with a known hypersensitivity to study drug or any component of the formulation of study drug (denatured ethanol)

10. Patients with prior participation in a study of ALprostadil

11. Patients participating in another research study within 30 days prior to screening (i.e., the day the informed consent is signed) or anticipated to enroll in such during the 24 weeks after screening

12. Patients for whom informed consent cannot be obtained