Biomarkers for Human Heart Failure

Completed

• Conditions: CHF

• Registration Number: NCT03905252
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-08
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-05
• Primary Completion: 2024-02
• Study Completion: 2024-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

Inclusion Criteria

• Diagnosis of Acute decompensated heart failure

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
uAGT levels in high-risk chronic HF patients	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.
Natriuretic peptide levels in ADHF patients	20 years	new knowledge of pathology and outcomes in ADHF patients

Trial Locations

Locations (1)

Mayo Foundation; 🇺🇸 Rochester, Minnesota, United States