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AzTrials

Heart FailurePOSTBIO-HFNCT04437628

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

An observational study of Heart Failure, run by Wonju Severance Christian Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
1,500 participants
Where
1 siteSouth Korea
Study dates
1 Feb 2021to 31 Dec 2025
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospitalized patients with acute decompensated heart failure

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Dong-Hyuk Cho, MD, PhD contact

82-33-741-0916

why012@gmail.com

South Korea1 site, 1 recruiting

  • Yonsei University Wonju College of Medicine

    Wŏnju, Gangwondo, 26426

    Dong-Hyuk Cho, MD, 82-33-741-0916, why012@gmail.com

    Recruiting

Other trials in South Korea

About this study

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.

Conditions
Heart Failure
Keywords
Heart failure, Biomarkers, Prognosis
Medical subject headings
Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (6)

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

    Any death after enrollment

    Measured: 12 months

  2. The incidence rate (%) of cardiovascular mortality

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

    Measured: 12 months

  3. The incidence rate (%) of hospital readmission

    Any readmission after discharge

    Measured: 12 months

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

    Readmission due to heart failure aggravation after discharge

    Measured: 12 months

  5. The incidence rate (%) of cerebrovascular events

    Stroke or intracranial hemorrhage

    Measured: 12 months

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

    Unstable angina or myocardial infarction

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2020
  2. Study start1 Feb 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04437628
Sponsor's protocol ID
CR320021
Acronym
POSTBIO-HF
Status last verified
Sep 2024
First submitted
16 Jun 2020
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Wonju Severance Christian Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dong-Hyuk Cho, MD, PhD (82-33-741-0916, why012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence rate (%) of composite endpoint including cardiovascular mortality or hospital readmission (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04437628, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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