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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04437628

Acronym

POSTBIO-HF

Enrollment

1500

Registered

2020-06-18

Start date

2021-02-01

Completion date

2025-12-31

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Biomarkers, Prognosis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The incidence rate (%) of composite endpoint including cardiovascular mortality or hospital readmission	12 months	Cardiovascular mortality: death due to heart failure aggravation, arrhythmia, cerebrovascular events, myocardial infarction. Hospital readmission: any readmission

Secondary

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

Countries

South Korea

Contacts

Primary ContactDong-Hyuk Cho, MD, PhD

why012@gmail.com82-33-741-0916

Outcome results