Biomarkers for Human Heart Failure (Biomarkers)

May 24, 2024 updated by: John C Burnett, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

535

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eight Hundred HF patients hospitalized for symptomatic HF at Mayo Clinic Hospital - St Mary's Campus, Rochester, Minnesota

Description

Inclusion Criteria:

• Diagnosis of Acute decompensated heart failure

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uAGT levels in high-risk chronic HF patients
Time Frame: 10 years
This study will provide new knowledge of the pathology and outcomes predicted by the use of uAGT in symptomatic chronic HF patients at high risk for future hospitalization and death.
10 years
Natriuretic peptide levels in ADHF patients
Time Frame: 20 years
new knowledge of pathology and outcomes in ADHF patients
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: John C Burnett, M.D., Mayo Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2009

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB # 09-003156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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