NCT00259038

Brief Summary

The study will evaluate the safety and efficacy of intravenous infusion of carperitide using pressure measurements inside the heart and great vessels and measuring carperitide concentration in the blood.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2004

Geographic Reach
2 countries

34 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

November 28, 2005

Last Update Submit

November 4, 2016

Conditions

Heart Failure, CongestiveHeart DecompensationLeft Ventricular FailureMyocardiopathiesSystolic or Diastolic Left Ventricular Dysfunction

Keywords

CarperitideAtrial Natriuretic PeptideTreatment efficacySafetyHeart failure, CongestivePulmonary Artery Catheterization

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pulmonary capillary wedge pressure (PCWP)

    at 3 hours following initiation of study drug infusion

Study Arms (2)

Experimental Drug

EXPERIMENTAL
Drug: Carperitide

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CarperitideDRUG
Also known as: human recombinant atrial natriuretic peptide
Experimental Drug
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Is hospitalized with congestive heart failure (CHF)
  • Has a Swan-Ganz catheter inserted for CHF management and has pulmonary capillary wedge pressure 18 mmHg or higher

You may not qualify if:

  • Has had a heart transplant
  • Requires mechanical ventilation or mechanical circulatory support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Unknown Facility

Huntsville, Alabama, 35801, United States

Location

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Bay Pines, Florida, 33744, United States

Location

Unknown Facility

Gainesville, Florida, 32610, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Orlando, Florida, 32803, United States

Location

Unknown Facility

St. Petersburg, Florida, 33707, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Springfield, Illinois, 62701, United States

Location

Unknown Facility

Covington, Louisiana, 70433, United States

Location

Unknown Facility

Shreveport, Louisiana, 71103, United States

Location

Unknown Facility

Baltimore, Maryland, 21201, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55455, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Albany, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, 45267, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Tulsa, Oklahoma, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Columbia, South Carolina, United States

Location

Unknown Facility

Amarillo, Texas, 79106, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Houston, Texas, 77225, United States

Location

Unknown Facility

Richmond, Virginia, 23298, United States

Location

Unknown Facility

Tacoma, Washington, 98405, United States

Location

Unknown Facility

Madison, Wisconsin, 53792, United States

Location

Unknown Facility

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 1X5, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Saint Foy, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Heart FailureCardiomyopathiesSystolic MurmursVentricular Dysfunction, Left

Interventions

NPPA protein, human

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart MurmursSigns and SymptomsPathological Conditions, Signs and SymptomsVentricular Dysfunction

Study Officials

  • Biljana Pavlovic-Surjancev, MD, PhD

    Astellas Pharma US, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 28, 2005

First Posted

November 29, 2005

Study Start

January 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

US(30)CA(4)