NCT00206856

Brief Summary

To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
Completed

Started Jul 2003

Typical duration for phase_4 heart-failure

Geographic Reach
1 country

29 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

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

July 29, 2013

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Last Update Submit

July 26, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.

Secondary Outcomes (1)

  • All-cause re-hospitalization, Quality of Life, 6 minute walk distance, New York Heart Association class and BNP.

Interventions

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older Patient was hospitalized and treated for heart failure Patient is fully stabilized at discharge Able to give informed consent

You may not qualify if:

  • History of severe pulmonary disease Chronic O2 therapy for COPD Primary pulmonary hypertension History of renal disease requiring dialysis History of severe hepatic disease Patients using LVAD's Stroke, MI, PTCA, CABG or unstable angina within the past 1 month Bi-ventricular pacemaker placement within last 1 month History of severe aortic stenosis History of severe mitral stenosis History of constrictive pericarditis Patient has had a cardiac transplant Status 1 cardiac transplant candidates ICD or DRG assignment of non-Q wave MI within last 1 month Patient has cor pulmonale A re-hospitalization, death or an IV treatment for heart failure before the first post-discharge visit and/or15) Planned chronic IV treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Scottsdale CardiovascularResearch

Scottsdale, Arizona, 85251, United States

Location

San Diego Veterans Administration Hospital

San Diego, California, 92161, United States

Location

San Francisco Veterans Administration Hospital

San Francisco, California, 94121-1545, United States

Location

Denver Veterans Administration Hospital

Denver, Colorado, 80220, United States

Location

Cardiology Associates of Fort Lauderdale

Fort Lauderdale, Florida, 33308, United States

Location

Shands at the University of Florida

Gainsville, Florida, 32610, United States

Location

VNH Heart Center Research

Port Charlotte, Florida, 33952, United States

Location

Heart and Vascular Institute of Florida

St. Petersburg, Florida, 33701, United States

Location

Northwestern University Memorial

Chicago, Illinois, 60611, United States

Location

Midwest Heart Institute

Lombard, Illinois, 60148, United States

Location

Advocate Health

Oak Lawn, Illinois, 60453, United States

Location

Oschner Clinic

New Orleans, Louisiana, 70121, United States

Location

University Mass. Memorial Hospital

Worcester, Massachusetts, 06155, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital-Troy

Troy, Michigan, 48085, United States

Location

Minnesota Veterans Administration

Minneapolis, Minnesota, 55417, United States

Location

Medicor Cardiology

Bridgewater, New Jersey, 08807, United States

Location

Buffalo Heart Group,

Buffalo, New York, 14215, United States

Location

Cardiovascular Medical Associates

Garden City, New York, 11530, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

South Bay Cardiovascular Associates

West Islip, New York, 11795, United States

Location

Carolinas Medical Center/Sanger Clinic

Charlotte, North Carolina, 28203, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0542, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44106, United States

Location

Cleveland University Hospital

Cleveland, Ohio, 44106, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Antonio VA Medical Center

San Antonio, Texas, 32610, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84143, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • James B Young, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2003

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

July 29, 2013

Record last verified: 2013-07

Locations