NCT00537628

Brief Summary

Primary Objectives

  1. 1.Mid Region pro Adrenomedullin (MR-proADM) is superior to BNP for the prognosis of heart failure (HF) patients and adds incremental value in predicting outcomes for patients presenting to the Emergency Department (ED) with shortness of breath.
  2. 2.Mid Region pro A-Type Natriuretic Peptide (MR-proANP) is non-inferior to BNP for the diagnosis of HF in patients presenting to the ED with shortness of breath.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,641

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
8 countries

15 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

March 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

Enrollment Period

1.2 years

First QC Date

September 28, 2007

Last Update Submit

July 30, 2008

Conditions

Shortness of BreathHeart Failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency Department

You may qualify if:

  • Eighteen years of age or older.
  • The patients must be seen in the urgent care or emergency area with a chief complaint of shortness of breath not due to trauma.

You may not qualify if:

  • Patient is unable to sign or understand the consent form.
  • Patient is on any dialysis.
  • Patient has trauma related shortness of breath (i.e. penetrating wounds, crush injury).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of California, San Diego

San Diego, California, 92103, United States

Location

Veterans Affairs Medical Center

San Diego, California, 92161, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55417, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Virgina Commonwealth University

Richmond, Virginia, 23298, United States

Location

Charite- Universitatsmedizin Berlin

Berlin, 13353, Germany

Location

Athens University Hospital Attikon

Athens, Greece

Location

University La Sapienza

Rome, 00189, Italy

Location

University of Otago

Christchurch, New Zealand

Location

Clinical Military Hospital

Wroclaw, 50-891, Poland

Location

University Hospital Basel

Basel, CH-4031, Switzerland

Location

University of Leicester

Leicester, LE2 7LX, United Kingdom

Location

Related Publications (5)

  • Maisel A, Neath SX, Landsberg J, Mueller C, Nowak RM, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng LL, Daniels LB, Christenson RH, Potocki M, McCord J, Terracciano G, Hartmann O, Bergmann A, Morgenthaler NG, Anker SD. Use of procalcitonin for the diagnosis of pneumonia in patients presenting with a chief complaint of dyspnoea: results from the BACH (Biomarkers in Acute Heart Failure) trial. Eur J Heart Fail. 2012 Mar;14(3):278-86. doi: 10.1093/eurjhf/hfr177. Epub 2012 Feb 2.

    PMID: 22302662DERIVED

  • Peacock WF, Nowak R, Christenson R, DiSomma S, Neath SX, Hartmann O, Mueller C, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Filippatos GS, Anand I, Ng LL, Daniels LB, Morgenthaler N, Anker SD, Maisel AS. Short-term mortality risk in emergency department acute heart failure. Acad Emerg Med. 2011 Sep;18(9):947-58. doi: 10.1111/j.1553-2712.2011.01150.x.

    PMID: 21906204DERIVED

  • Maisel A, Mueller C, Nowak RM, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng LL, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Hartmann O, Morgenthaler NG, Anker SD. Midregion prohormone adrenomedullin and prognosis in patients presenting with acute dyspnea: results from the BACH (Biomarkers in Acute Heart Failure) trial. J Am Coll Cardiol. 2011 Aug 30;58(10):1057-67. doi: 10.1016/j.jacc.2011.06.006.

    PMID: 21867843DERIVED

  • Maisel A, Xue Y, Shah K, Mueller C, Nowak R, Peacock WF, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand IS, Ng L, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Terracciano G, Kremastinos D, Hartmann O, von Haehling S, Bergmann A, Morgenthaler NG, Anker SD. Increased 90-day mortality in patients with acute heart failure with elevated copeptin: secondary results from the Biomarkers in Acute Heart Failure (BACH) study. Circ Heart Fail. 2011 Sep;4(5):613-20. doi: 10.1161/CIRCHEARTFAILURE.110.960096. Epub 2011 Jul 15.

    PMID: 21765124DERIVED

  • Maisel A, Mueller C, Nowak R, Peacock WF, Landsberg JW, Ponikowski P, Mockel M, Hogan C, Wu AH, Richards M, Clopton P, Filippatos GS, Di Somma S, Anand I, Ng L, Daniels LB, Neath SX, Christenson R, Potocki M, McCord J, Terracciano G, Kremastinos D, Hartmann O, von Haehling S, Bergmann A, Morgenthaler NG, Anker SD. Mid-region pro-hormone markers for diagnosis and prognosis in acute dyspnea: results from the BACH (Biomarkers in Acute Heart Failure) trial. J Am Coll Cardiol. 2010 May 11;55(19):2062-76. doi: 10.1016/j.jacc.2010.02.025.

    PMID: 20447528DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

DyspneaHeart Failure

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Alan S Maisel, MD

    Veterans Affairs Medical Center, San Diego and University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • Stefan D Anker, MD, PhD

    Universitätsklinikum Charité, Charité - Campus Virchow

    PRINCIPAL INVESTIGATOR

  • Frank Peacock, MD

    The Cleveland Clinic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2007

First Posted

October 1, 2007

Study Start

March 1, 2007

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

August 1, 2008

Record last verified: 2008-07

Locations

IT(1)GB(1)US(8)CH(1)DE(1)GR(1)PL(1)NZ(1)