Clinical trial NCT04437628: Prognostic Value Of Short-Term Follow-up Biomarkers After Discharge In hOspitalized Patients With Acute Heart Failure
Official title: Prognostic Value Of Short-Term Follow-up Biomarkers After Discharge In hOspitalized Patients With Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: Heart failure
Biomarkers
Prognosis
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
Collaborators: name: Roche diagnostics Korea
First posted: 2020-06-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients with acute decompensated heart failure

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence rate (%) of composite endpoint including cardiovascular mortality or hospital readmission
timeFrame: 12 months
Secondary outcomes:
measure: The incidence rate (%) of all cause mortality
timeFrame: 12 months
measure: The incidence rate (%) of cardiovascular mortality
timeFrame: 12 months
measure: The incidence rate (%) of hospital readmission
timeFrame: 12 months
measure: The incidence rate (%) of hospital readmission due to heart failure aggravation
timeFrame: 12 months
measure: The incidence rate (%) of cerebrovascular events
timeFrame: 12 months
measure: The incidence rate (%) of acute coronary syndrome
timeFrame: 12 months
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju College of Medicine
state: Gangwondo
Study officials:
affiliation: Wonju College of Medicine, Yonsei University
name: Byung-Su Yoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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