ClinicalTrials.gg
Status unknownNCT04437628POSTBIO-HFUpdated Sep 19, 2024

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

An observational study in Heart Failure, sponsored by Wonju Severance Christian Hospital. Status unknown at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Wonju Severance Christian Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Heart Failure

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Keywords

  • Heart failure
  • Biomarkers
  • Prognosis
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Wonju Severance Christian Hospital is the lead sponsor of 43 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
None retained
06

What researchers measure

Primary outcomes

  1. The incidence rate (%) of composite endpoint including cardiovascular mortality or hospital readmission

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

    Time frame: 12 months

Secondary outcomes

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

    Any death after enrollment

    Time frame: 12 months

  2. The incidence rate (%) of cardiovascular mortality

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

    Time frame: 12 months

  3. The incidence rate (%) of hospital readmission

    Any readmission after discharge

    Time frame: 12 months

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

    Readmission due to heart failure aggravation after discharge

    Time frame: 12 months

  5. The incidence rate (%) of cerebrovascular events

    Stroke or intracranial hemorrhage

    Time frame: 12 months

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

    Unstable angina or myocardial infarction

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
  • Yonsei University Wonju College of Medicine
    Wŏnju, Gangwondo 26426, South Korea
    Recruiting
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References and documents

Publications

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available. PubMed 27207191 ↗
  • Lee SE, Lee HY, Cho HJ, Choe WS, Kim H, Choi JO, Jeon ES, Kim MS, Kim JJ, Hwang KK, Chae SC, Baek SH, Kang SM, Choi DJ, Yoo BS, Kim KH, Park HY, Cho MC, Oh BH. Clinical Characteristics and Outcome of Acute Heart Failure in Korea: Results from the Korean Acute Heart Failure Registry (KorAHF). Korean Circ J. 2017 May;47(3):341-353. doi: 10.4070/kcj.2016.0419. Epub 2017 May 25. PubMed 28567084 ↗
  • Lee SE, Cho HJ, Lee HY, Yang HM, Choi JO, Jeon ES, Kim MS, Kim JJ, Hwang KK, Chae SC, Seo SM, Baek SH, Kang SM, Oh IY, Choi DJ, Yoo BS, Ahn Y, Park HY, Cho MC, Oh BH. A multicentre cohort study of acute heart failure syndromes in Korea: rationale, design, and interim observations of the Korean Acute Heart Failure (KorAHF) registry. Eur J Heart Fail. 2014 Jun;16(6):700-8. doi: 10.1002/ejhf.91. Epub 2014 May 2. PubMed 24797348 ↗
  • Kempf T, Eden M, Strelau J, Naguib M, Willenbockel C, Tongers J, Heineke J, Kotlarz D, Xu J, Molkentin JD, Niessen HW, Drexler H, Wollert KC. The transforming growth factor-beta superfamily member growth-differentiation factor-15 protects the heart from ischemia/reperfusion injury. Circ Res. 2006 Feb 17;98(3):351-60. doi: 10.1161/01.RES.0000202805.73038.48. Epub 2006 Jan 5. PubMed 16397141 ↗
  • Kempf T, Zarbock A, Widera C, Butz S, Stadtmann A, Rossaint J, Bolomini-Vittori M, Korf-Klingebiel M, Napp LC, Hansen B, Kanwischer A, Bavendiek U, Beutel G, Hapke M, Sauer MG, Laudanna C, Hogg N, Vestweber D, Wollert KC. GDF-15 is an inhibitor of leukocyte integrin activation required for survival after myocardial infarction in mice. Nat Med. 2011 May;17(5):581-8. doi: 10.1038/nm.2354. Epub 2011 Apr 24. PubMed 21516086 ↗
  • Xu XY, Nie Y, Wang FF, Bai Y, Lv ZZ, Zhang YY, Li ZJ, Gao W. Growth differentiation factor (GDF)-15 blocks norepinephrine-induced myocardial hypertrophy via a novel pathway involving inhibition of epidermal growth factor receptor transactivation. J Biol Chem. 2014 Apr 4;289(14):10084-94. doi: 10.1074/jbc.M113.516278. Epub 2014 Feb 19. PubMed 24554716 ↗
  • Dominguez-Rodriguez A, Abreu-Gonzalez P, Avanzas P. Relation of growth-differentiation factor 15 to left ventricular remodeling in ST-segment elevation myocardial infarction. Am J Cardiol. 2011 Oct 1;108(7):955-8. doi: 10.1016/j.amjcard.2011.05.028. Epub 2011 Jul 23. PubMed 21784389 ↗
  • Kempf T, von Haehling S, Peter T, Allhoff T, Cicoira M, Doehner W, Ponikowski P, Filippatos GS, Rozentryt P, Drexler H, Anker SD, Wollert KC. Prognostic utility of growth differentiation factor-15 in patients with chronic heart failure. J Am Coll Cardiol. 2007 Sep 11;50(11):1054-60. doi: 10.1016/j.jacc.2007.04.091. Epub 2007 Aug 24. PubMed 17825714 ↗
  • Cotter G, Voors AA, Prescott MF, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Milo O, Hua TA, Qian M, Severin TM, Teerlink JR, Metra M, Davison BA. Growth differentiation factor 15 (GDF-15) in patients admitted for acute heart failure: results from the RELAX-AHF study. Eur J Heart Fail. 2015 Nov;17(11):1133-43. doi: 10.1002/ejhf.331. Epub 2015 Sep 3. PubMed 26333529 ↗
  • Redfield MM. Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2016 Nov 10;375(19):1868-1877. doi: 10.1056/NEJMcp1511175. No abstract available. PubMed 27959663 ↗
  • Chan MM, Santhanakrishnan R, Chong JP, Chen Z, Tai BC, Liew OW, Ng TP, Ling LH, Sim D, Leong KT, Yeo PS, Ong HY, Jaufeerally F, Wong RC, Chai P, Low AF, Richards AM, Lam CS. Growth differentiation factor 15 in heart failure with preserved vs. reduced ejection fraction. Eur J Heart Fail. 2016 Jan;18(1):81-8. doi: 10.1002/ejhf.431. Epub 2015 Oct 25. PubMed 26497848 ↗
  • Cho DH, Son JW, Lee CJ, Choi J, Kim MN, Lee JH, Lee S, Yang DH, Cho HJ, Choi JO, Kim EJ, Choi DJ, Yoo BS. Prognostic Value of Short-Term Follow-up of Multiple Biomarkers After Discharge in Hospitalized Patients With Acute Heart Failure (POSTBIO-HF): Rationale and Study Design. Int J Heart Fail. 2022 Apr 4;4(2):110-116. doi: 10.36628/ijhf.2022.0005. eCollection 2022 Apr. PubMed 36263107 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2021 (actual). Primary completion is estimated for Dec 2024, 46 months after the start.

Of 665 non-industry observational studies under Heart Failure, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 89. This study's planned 46 months is close to that.

Counting every sponsor, half of 825 studies reached it within 40 months; a quarter within 21 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 16, 2020
First posted
Jun 18, 2020
StartActual
Feb 1, 2021
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2025
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04437628
Lead sponsor
Wonju Severance Christian Hospital
Collaborators
Roche diagnostics Korea
Responsible party
Byung-Su Yoo (Professor, Wonju Severance Christian Hospital) — Principal investigator
First posted
Jun 18, 2020
Start date
Feb 1, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Dong-Hyuk Cho, MD, PhD
Contact
why012@gmail.com
82-33-741-0916
Byung-Su Yoo, MD, PhD
principal investigator · Wonju College of Medicine, Yonsei University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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