NCT00338455

Brief Summary

The purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country equivalent) cardiac transplant candidates are to assess the safety and efficacy of Natrecor (nesiritide). The study will evaluate the drug's ability to prevent clinical worsening when administered as a 28-day continuous intravenous infusion in patients receiving standard care and continuous intravenous infusion of dobutamine or milrinone.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 5, 2008

Completed
Last Updated

December 8, 2014

Status Verified

November 1, 2014

Enrollment Period

1.1 years

First QC Date

June 16, 2006

Results QC Date

October 22, 2008

Last Update Submit

November 20, 2014

Conditions

Congestive Heart FailureCardiac TransplantationRenal InsufficiencyRenal Failure

Keywords

Congestive heart failurecardiac transplantationrenal insufficiencyrenal failuredialysisultrafiltrationvasodilatorNatrecor (nesiritide)

Outcome Measures

Primary Outcomes (1)

  • Number of Days Alive Without Renal, Hemodynamic, or Electrical Clinical Worsening Through Day 28 (Termination of Treatment)

    Number of calendar days alive without renal, hemodynamic, or electrical clinical worsening through Day 28 (termination of treatment or early discontinuation of treatment, whichever occurred first). The endpoint was not normalized for time on study.

    28 days

Secondary Outcomes (3)

  • Changes in Pulmonary Capillary Wedge Pressure (PCWP)

    28 days

  • All Cause Mortality

    Day 30 and Months 2 and 6

  • Changes in Pulmonary Artery Pressure (PAP): Systolic, Diastolic, and Mean

    28 days

Study Arms (2)

001

EXPERIMENTAL

Natrecor (nesiritide)+Standard Care+dobutamine or milrinone 28-day continuous infusion no bolus 3-hour 0.005 mcg/kg/min may be titrated to 0.015 mcg/kg/min

Drug: Natrecor (nesiritide)+Standard Care+dobutamine or milrinone

002

PLACEBO COMPARATOR

Placebo+Standard Care+dobutamine or milrinone 28-day continuous infusion no bolus 3-hour 0.005 mcg/kg/min may be titrated to 0.015 mcg/kg/min

Drug: Placebo+Standard Care+dobutamine or milrinone

Interventions

Natrecor (nesiritide)+Standard Care+dobutamine or milrinoneDRUG

3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min

001
Placebo+Standard Care+dobutamine or milrinoneDRUG

28-day continuous infusion, no bolus

002

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the criteria for a United Network for Organ Sharing (UNOS) Status 1B heart transplant candidate, or, if outside the US, have comparable status
  • must also be a primary transplant candidate waiting to receive a single cardiac allograft
  • must be receiving continuous intravenous infusion of dobutamine or milrinone through a double-lumen central catheter or a double-lumen percutaneously inserted central catheter for at least 3 consecutive days before randomization
  • must be willing and able to participate in the study assessments and follow up procedures
  • male and female subjects of childbearing potential agree to use two highly effective methods of birth control for the duration of the study.

You may not qualify if:

  • Not have systolic blood pressure (SBP) consistently \< 80 mm Hg, or have clinically significant orthostatic hypotension
  • not weigh \> 130 kg
  • not have a ventricular assist device (VAD), or anticipate the need for a VAD, during the 28-day study drug treatment period
  • not have received placement of an internal cardiac defibrillator (ICD) or external cardiac defibrillator (ECD) within 72 hours before randomization
  • not require chronic hemodialysis or peritoneal dialysis to treat renal failure, or had acute dialysis or ultrafiltration within 7 days before randomization
  • not have received antibiotic treatment within 7 days before randomization-antibiotics are permissible for any prophylactic use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Maywood, Illinois, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Heart FailureRenal Insufficiency

Interventions

Natriuretic Peptide, BrainMilrinone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsAmrinoneAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Early termination of the study due to enrollment difficulties (change in standard of care for patient population as well as changing organ allocation rules by United Network for Organ Sharing); efficacy not analyzed due to limited sample size (n=16).

Results Point of Contact

Title
Sr. Director Clinical Leader
Organization
Scios R&D, Inc.
650 564-5084

Study Officials

  • Scios, Inc. Clinical Trial

    Scios, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

September 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

December 8, 2014

Results First Posted

December 5, 2008

Record last verified: 2014-11

Locations

US(14)