Biomarkers for Human Heart Failure

CHF Clinical Trial

— Biomarkers  

Official title:

Biomarkers for Human Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905252
• Other study ID #: IRB # 09-003156
• Status: Completed
• Start date: August 2009
• Est. completion date: February 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 535
• Est. completion date: February 2024
• Est. primary completion date: February 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

Related Conditions & MeSH terms

• CHF
• Heart Failure

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