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

NCT04437628 | Recruiting DMC

• 1 other identifier: CR320021
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; Biomarkers; Prognosis

Outcome Measures

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

  12 months

Secondary Outcomes (6)

• The incidence rate (%) of all cause mortality

  12 months

• The incidence rate (%) of cardiovascular mortality

  12 months

• The incidence rate (%) of hospital readmission

  12 months

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

  12 months

• The incidence rate (%) of cerebrovascular events

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized patients with acute decompensated heart failure

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• Roche diagnostics Korea: collaborator

Study Sites (1)

Yonsei University Wonju College of Medicine

Wŏnju, Gangwondo, 26426, South Korea

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 36263107 DERIVED

Biospecimen

Retention: NONE RETAINED

Blood sample for biomarker analysis (NP and GDF-15) within 30 days and at 6 months (±1 month) after discharge

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Byung-Su Yoo, MD, PhD

  Wonju College of Medicine, Yonsei University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Hyuk Cho, MD, PhD

CONTACT

82-33-741-0916; why012@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: February 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)