NCT03905252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
535

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

14.5 years

First QC Date

April 4, 2019

Last Update Submit

May 24, 2024

Conditions

CHF

Outcome Measures

Primary Outcomes (2)

  • 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

  • Natriuretic peptide levels in ADHF patients

    new knowledge of pathology and outcomes in ADHF patients

    20 years

Interventions

sample analysisOTHER

blood, Random urine sample and 24-hour urine samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Diagnosis of Acute decompensated heart failure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Foundation

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

: Single blood draw, random urine and 24-hr urine collection

Study Officials

  • John C Burnett, M.D.

    Mayo Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 5, 2019

Study Start

August 1, 2009

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)