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NCT Number: NCT04437628

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Wonju College of Medicine

Wŏnju, Gangwondo, 26426, South Korea

Location status: Recruiting

Location contact

Dong-Hyuk Cho, MD

CONTACT

[email protected]

82-33-741-0916

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

the diagnosis of Heart failure requires the following

  • heart failure with reduced ejection fraction ( A 'reduced' ejection fraction (EF) defined as EF <40%): the presence of symptoms and/or signs of HF
  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. The incidence rate (%) of all cause mortality

    Time frame: 12 months

    Any death after enrollment

  2. The incidence rate (%) of cardiovascular mortality

    Time frame: 12 months

    Death due to heart failure aggravation, arrhythmia, cerebrovascular events, myocardial infarction.

  3. The incidence rate (%) of hospital readmission

    Time frame: 12 months

    Any readmission after discharge

  4. The incidence rate (%) of hospital readmission due to heart failure aggravation

    Time frame: 12 months

    Readmission due to heart failure aggravation after discharge

  5. The incidence rate (%) of cerebrovascular events

    Time frame: 12 months

    Stroke or intracranial hemorrhage

  6. The incidence rate (%) of acute coronary syndrome

    Time frame: 12 months

    Unstable angina or myocardial infarction

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-Hyuk Cho, MD, PhD

CONTACT

[email protected]

82-33-741-0916

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Collaborators

  • Roche diagnostics Korea

Registry information

Acronym: POSTBIO-HF

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jun 18, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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