Prognostic Value Of Short-Term Follow-up Biomarkers After Discharge In hOspitalized Patients With Acute Heart Failure (POSTBIO-HF)

July 30, 2023 updated by: Byung-Su Yoo, Wonju Severance Christian Hospital
Several surrogate biomarkers including natriuretic peptide(NP), and growth differentiation factor-15(GDF-15) and ST2 has prognostic significance in heart failure(HF), and reductions in its value may predict clinical improvement. However, there are limited data regarding the prognostic value of these biomarkers during short-term follow-up after discharge in acute decompensated heart failure. The purpose of this study is to evaluate the prognostic value of short-term follow-up surrogate biomarkers for predicting prognosis of hospitalized patients with acute decompensated heart failure.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dong-Hyuk Cho, MD, PhD
  • Phone Number: 82-33-741-0916
  • Email: why012@gmail.com

Study Locations

  • Korea, Republic of
    • Gangwondo
      • Wonju, Gangwondo, Korea, Republic of, 26426
        • Recruiting
        • Yonsei University Wonju College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Hospitalized patients with acute decompensated heart failure

Description

Inclusion Criteria: the diagnosis of Heart failure requires the following

  1. heart failure with reduced ejection fraction ( A 'reduced' ejection fraction (EF) defined as EF <40%): the presence of symptoms and/or signs of HF
  2. heart failure with preserved ejection fraction ( A 'preserved' EF defined as EF≥ 40%) requires the all of the followings: a) the presence of symptoms and/or signs of HF b) elevated levels of natriuretic peptides (defined as B-type natriuretic peptide (BNP) >100pg/ml and/or N terminal B-type natriuretic peptide (NT-proBNP) >300pg/ml) c) any structural heart disease (left atrial volume index ≥ 34 mL/m2, left atrial dimension ≥ 50 mm, posterior or septal wall thickness ≥ 11mm)

Exclusion Criteria:

  • any severe condition limiting life less than 3 months
  • the patient is not ready to contact by telephone at the end of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate (%) of composite endpoint including cardiovascular mortality or hospital readmission
Time Frame: 12 months

Cardiovascular mortality: death due to heart failure aggravation, arrhythmia, cerebrovascular events, myocardial infarction.

Hospital readmission: any readmission
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate (%) of all cause mortality
Time Frame: 12 months
Any death after enrollment
12 months
The incidence rate (%) of cardiovascular mortality
Time Frame: 12 months
Death due to heart failure aggravation, arrhythmia, cerebrovascular events, myocardial infarction.
12 months
The incidence rate (%) of hospital readmission
Time Frame: 12 months
Any readmission after discharge
12 months
The incidence rate (%) of hospital readmission due to heart failure aggravation
Time Frame: 12 months
Readmission due to heart failure aggravation after discharge
12 months
The incidence rate (%) of cerebrovascular events
Time Frame: 12 months
Stroke or intracranial hemorrhage
12 months
The incidence rate (%) of acute coronary syndrome
Time Frame: 12 months
Unstable angina or myocardial infarction
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonju Severance Christian Hospital

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Byung-Su Yoo, MD, PhD, Wonju College of Medicine, Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR320021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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