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Biomarkers for Human Heart Failure (Biomarkers)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905252
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
John C Burnett, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
CHF Other: sample analysis

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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biomarkers for Human Heart Failure
Study Start Date : August 2009
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Other: sample analysis
    blood, Random urine sample and 24-hour urine samples


Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
: Single blood draw, random urine and 24-hr urine collection


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

• Diagnosis of Acute decompensated heart failure

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905252


Contacts
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Contact: Seethalakshmi R Iyer, MS 507-284-4838 iyer.seethalakshmi@mayo.edu
Contact: Emery (John) van Hook 507-284-4838 VanHook.Emery@mayo.edu

Locations
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United States, Minnesota
Mayo Foundation Recruiting
Rochester, Minnesota, United States, 55905
Contact: Seethalakshmi Iyer, MS    507-284-4838    iyer.seethalakshmi@mayo.edu   
Contact: Emery (John) Van Hook    507-284-4838    VanHook.Emery@mayo.edu   
Principal Investigator: John C Burnett, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: John C Burnett, M.D. Mayo Foundation
Additional Information:
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Responsible Party: John C Burnett, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03905252    
Other Study ID Numbers: IRB # 09-003156
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases