Biomarkers for Human Heart Failure

NCT ID: NCT03905252

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

535 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2024-02-29

Brief Summary

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The purpose of this study is to establish the various ranges of proteins that can be assayed in the plasma and urine from hospitalized patients with all classes of heart failure and/or STEMI (ST-segment elevation myocardial infarction)/NSTEMI (Non-ST-segment elevation myocardial infarction), as well as history reviews.

Detailed Description

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Schematic Design of the Study: Single blood draw, one random urine and 24-hr urine collection from hospitalized patients with chronic/acute heart failure and/or STEMI-NSTEMI. If there should be a subsequent hospitalization,another collection of a 45 ml blood sample, random urine and one 24-hour urine collection may be completed if indicated at initial hospitalization.

Aims:

The purpose of this study is to attempt to establish the various ranges of proteins that can be assayed from the plasma and urine of patients with all classes of heart failure and MI (myocardial infarction). Follow-up hospitalizations may result in another 45 ml blood draw, random urine and 24-hr. urine collection to evaluate the outcome of the heart failure treatment used with the previous hospitalization, if indicated in consent. A history review will be necessary as well.

Conditions

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CHF

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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sample analysis

blood, Random urine sample and 24-hour urine samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• Diagnosis of Acute decompensated heart failure

Exclusion Criteria

• Hemoglobin less than 10, active cancer, or amyloidosis Patient with dialysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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John C Burnett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John C Burnett, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Foundation

Locations

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Mayo Foundation

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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IRB # 09-003156

Identifier Type: -

Identifier Source: org_study_id

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