Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00537628




Registration number
NCT00537628
Ethics application status
Date submitted
28/09/2007
Date registered
1/10/2007
Date last updated
1/08/2008

Titles & IDs
Public title
Biomarkers in Acute Heart Failure
Scientific title
Biomarkers in Acute Heart Failure: An International, Multi-Center Trial Evaluating the Prognostic and Diagnostic Utility of Biomarkers in Patients With Heart Failure Presenting With Shortness of Breath
Secondary ID [1] 0 0
Brahms
Universal Trial Number (UTN)
Trial acronym
BACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shortness of Breath 0 0
Heart Failure 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
1641
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Greece
State/province [8] 0 0
Athens
Country [9] 0 0
Italy
State/province [9] 0 0
Rome
Country [10] 0 0
New Zealand
State/province [10] 0 0
Christchurch
Country [11] 0 0
Poland
State/province [11] 0 0
Wroclaw
Country [12] 0 0
Switzerland
State/province [12] 0 0
Basel
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Brahms AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objectives

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. 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 website
https://clinicaltrials.gov/ct2/show/NCT00537628
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alan S Maisel, MD
Address 0 0
Veterans Affairs Medical Center, San Diego and University of California, San Diego
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00537628