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

This study has suspended participant recruitment.
(DD issue)
Sponsor:
Information provided by:
Biopeutics Co., Ltd
ClinicalTrials.gov Identifier:
NCT00610051
First received: January 14, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Heart Failure
Drug: Alprostadil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Alprostadil Continuous Intravenous Infusion in Bridging Cardiac Transplant in Severe Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Biopeutics Co., Ltd:

Primary Outcome Measures:
  • To evaluate the efficacy and tolerability given in a continuous fixed low dose intravenous infusion in bridging patients with severe heart failure during waiting time for cardiac transplantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess both overall survival and cardiovascular-specific mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To assess transplantation success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To evaluate the effect of Alprostadil on Nt-proBNP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
compare the efficacy of Alprostadil with placebo
Drug: Alprostadil
central venous access continuous delivery with 2.5ng/kg/min
Other Name: Papeilin

Detailed Description:

During the Screening Phase, informed consent will be obtained and information to establish eligibility for transplant and all other inclusion and exclusion criteria will be assessed. The screening activities may be performed on an outpatient basis in stable patients or as an inpatient in unstable patients who are already hospitalized.

Throughout the study, patients will be maintained medically in accordance with the national Guidelines for heart failure, which are mostly based on the European Guidelines for Heart Failure (2005) and the American Guidelines for Heart Failure, The primary assessment of efficacy is based on the number of days that the patient is hospitalized or is deceased during the 24 weeks following the day of randomization, As elective transplantation is biased by donor availability, observation period in those cases will be counted until ELECTIVE heart transplantation. Additional surrogate measures of efficacy will include monthly assessments of Nt-proBNP, patient assessment of dyspnoea, Minnesota Living with Heart Failure Questionnaire, NYHA classification, and use of beta1-blocker therapy.

Study Population It is planned that a sufficient number of patients will be screened to enroll 500 patients (250 patients per treatment group). Compliance with the inclusion and exclusion criteria outlined below must be established prior to randomization to double-blind therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610051

Locations
Austria
University of Vienna
Vienna, Austria
Sponsors and Collaborators
Biopeutics Co., Ltd
Investigators
Principal Investigator: Richard Pacher, MD University Of Vienna, Department of Cardiology
  More Information

No publications provided

Responsible Party: Biopeutics Co., Ltd
ClinicalTrials.gov Identifier: NCT00610051     History of Changes
Other Study ID Numbers: 3-T02-07-0105
Study First Received: January 14, 2008
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Biopeutics Co., Ltd:
severe heart failure
transplants

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Alprostadil
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014