<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04437628</url>
  </required_header>
  <id_info>
    <org_study_id>CR320021</org_study_id>
    <nct_id>NCT04437628</nct_id>
  </id_info>
  <brief_title>Prognostic Value Of Short-Term Follow-up Biomarkers After Discharge In hOspitalized Patients With Acute Heart Failure</brief_title>
  <acronym>POSTBIO-HF</acronym>
  <official_title>Prognostic Value Of Short-Term Follow-up Biomarkers After Discharge In hOspitalized Patients With Acute Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wonju Severance Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wonju Severance Christian Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several surrogate biomarkers including natriuretic peptide(NP), and growth differentiation&#xD;
      factor-15(GDF-15) and ST2 has prognostic significance in heart failure(HF), and reductions in&#xD;
      its value may predict clinical improvement. However, there are limited data regarding the&#xD;
      prognostic value of these biomarkers during short-term follow-up after discharge in acute&#xD;
      decompensated heart failure. The purpose of this study is to evaluate the prognostic value of&#xD;
      short-term follow-up surrogate biomarkers for predicting prognosis of hospitalized patients&#xD;
      with acute decompensated heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>The incidence rate (%) of composite endpoint including cardiovascular mortality or hospital readmission</measure>
    <time_frame>12 months</time_frame>
    <description>Cardiovascular mortality: death due to heart failure aggravation, arrhythmia, cerebrovascular events, myocardial infarction.&#xD;
Hospital readmission: any readmission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence rate (%) of all cause mortality</measure>
    <time_frame>12 months</time_frame>
    <description>Any death after enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence rate (%) of cardiovascular mortality</measure>
    <time_frame>12 months</time_frame>
    <description>Death due to heart failure aggravation, arrhythmia, cerebrovascular events, myocardial infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence rate (%) of hospital readmission</measure>
    <time_frame>12 months</time_frame>
    <description>Any readmission after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence rate (%) of hospital readmission due to heart failure aggravation</measure>
    <time_frame>12 months</time_frame>
    <description>Readmission due to heart failure aggravation after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence rate (%) of cerebrovascular events</measure>
    <time_frame>12 months</time_frame>
    <description>Stroke or intracranial hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence rate (%) of acute coronary syndrome</measure>
    <time_frame>12 months</time_frame>
    <description>Unstable angina or myocardial infarction</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Heart Failure</condition>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood sample for biomarker analysis (NP and GDF-15) within 30 days and at 6 months (±1 month)&#xD;
      after discharge&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients with acute decompensated heart failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: the diagnosis of Heart failure requires the following&#xD;
&#xD;
          1. heart failure with reduced ejection fraction ( A 'reduced' ejection fraction (EF)&#xD;
             defined as EF &lt;40%): the presence of symptoms and/or signs of HF&#xD;
&#xD;
          2. heart failure with preserved ejection fraction ( A 'preserved' EF defined as EF≥ 40%)&#xD;
             requires the all of the followings: a) the presence of symptoms and/or signs of HF b)&#xD;
             elevated levels of natriuretic peptides (defined as B-type natriuretic peptide (BNP)&#xD;
             &gt;100pg/ml and/or N terminal B-type natriuretic peptide (NT-proBNP) &gt;300pg/ml) c) any&#xD;
             structural heart disease (left atrial volume index ≥ 34 mL/m2, left atrial dimension ≥&#xD;
             50 mm, posterior or septal wall thickness ≥ 11mm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any severe condition limiting life less than 3 months&#xD;
&#xD;
          -  the patient is not ready to contact by telephone at the end of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Byung-Su Yoo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wonju College of Medicine, Yonsei University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dong-Hyuk Cho, MD, PhD</last_name>
    <phone>82-33-741-0916</phone>
    <email>why012@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yonsei University Wonju College of Medicine</name>
      <address>
        <city>Wonju</city>
        <state>Gangwondo</state>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dong-Hyuk Cho, MD</last_name>
      <phone>82-33-741-0916</phone>
      <email>why012@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>27207191</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28567084</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24797348</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16397141</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21516086</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24554716</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21784389</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17825714</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26333529</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27959663</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26497848</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>July 30, 2023</last_update_submitted>
  <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wonju Severance Christian Hospital</investigator_affiliation>
    <investigator_full_name>Byung-Su Yoo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Heart failure</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04437628
org study id: CR320021
nct id: NCT04437628
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: The incidence rate (%) of composite endpoint including cardiovascular mortality or hospital readmission
time frame: 12 months
description: Cardiovascular mortality: death due to heart failure aggravation, arrhythmia, cerebrovascular events, myocardial infarction.
Hospital readmission: any readmission
measure: The incidence rate (%) of all cause mortality
time frame: 12 months
description: Any death after enrollment
measure: The incidence rate (%) of cardiovascular mortality
time frame: 12 months
description: Death due to heart failure aggravation, arrhythmia, cerebrovascular events, myocardial infarction.
measure: The incidence rate (%) of hospital readmission
time frame: 12 months
description: Any readmission after discharge
measure: The incidence rate (%) of hospital readmission due to heart failure aggravation
time frame: 12 months
description: Readmission due to heart failure aggravation after discharge
measure: The incidence rate (%) of cerebrovascular events
time frame: 12 months
description: Stroke or intracranial hemorrhage
measure: The incidence rate (%) of acute coronary syndrome
time frame: 12 months
description: Unstable angina or myocardial infarction
Blood sample for biomarker analysis (NP and GDF-15) within 30 days and at 6 months (±1 month)
      after discharge
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Byung-Su Yoo, MD, PhD
role: Principal Investigator
affiliation: Wonju College of Medicine, Yonsei University
last name: Dong-Hyuk Cho, MD, PhD
phone: 82-33-741-0916
email: why012@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: 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.
PMID: 27207191
citation: 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.
PMID: 28567084
citation: 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.
PMID: 24797348
citation: 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.
PMID: 16397141
citation: 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.
PMID: 21516086
citation: 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.
PMID: 24554716
citation: 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.
PMID: 21784389
citation: 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.
PMID: 17825714
citation: 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.
PMID: 26333529
citation: 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.
PMID: 27959663
citation: 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.
PMID: 26497848
responsible party type: Principal Investigator
investigator affiliation: Wonju Severance Christian Hospital
investigator full name: Byung-Su Yoo
investigator title: Professor
mesh term: Heart Failure
sharing ipd: No