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NCT03905252 Clinical Trial

Biomarkers for Human Heart Failure

CHF Clinical Trial

— Biomarkers  

Official title:
Biomarkers for Human Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03905252
Other study ID # IRB # 09-003156
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2009
Est. completion date December 2025

Study information
Verified date February 2023
Source Mayo Clinic
Contact Seethalakshmi R Iyer, MS
Phone 507-284-4838
Email iyer.seethalakshmi@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 800
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: • Diagnosis of Acute decompensated heart failure Exclusion Criteria: • Hemoglobin less than 10, active cancer, or amyloidosis Patient with dialysis

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Foundation Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary uAGT levels in high-risk chronic HF patients 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
Primary Natriuretic peptide levels in ADHF patients new knowledge of pathology and outcomes in ADHF patients 20 years
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