Skip to main content
SpringerLink
Log in

Study protocol for prospect trial to elucidate the utility of echocardiography-based cardiac output in acute heart failure (PREDICT)

  • Original Investigation
  • Published:
Journal of Echocardiography Aims and scope Submit manuscript

Abstract

Background

Early worsening heart failure (WHF), defined as worsening of symptoms and signs of heart failure requiring intensification of medical or mechanical therapy during an admission for acute decompensated heart failure (ADHF), has recently been recognized as a risk of morbidity or mortality after the discharge. Although echocardiographic parameters of left ventricular (LV) output has been shown to be associated with long-term outcome in heart failure patients, its predictive value for early WHF has not been elucidated.

Methods

Prospect trial to Elucidate the utility of EchocarDiography-based Cardiac output in acute heart failure (PREDICT) is a multicenter, nonrandomized, prospective observational study to test the predictive value of echocardiographic LV output parameters for early WHF in ADHF patients. We will enroll patients admitted to 16 participating hospitals due to ADHF who did not receive positive inotropic agents as an initial therapy. Primary outcome will be set at early WHF defined as need for initiation of positive inotropic agents within 7 days after the admission. Predictive accuracy will be compared between Doppler echocardiographic LV output (stroke distance, stroke volume index, and cardiac index) and low perfusion findings assessed by physical examination.

Results

N/A.

Conclusions

The PREDICT is expected to provide large data set to test the predictive value of echocardiographic LV output for early WHF in ADHF patients.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart disease and stroke statistics-2017 update: a report from the American heart association. Circulation. 2017;135:e146–e603.

    PubMed  PubMed Central  Google Scholar 

  2. Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart. 2007;93:1137–46.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Ambrosy AP, Fonarow GC, Butler J, et al. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014;63:1123–33.

    Article  PubMed  Google Scholar 

  4. Torre-Amione G, Milo-Cotter O, Kaluski E, et al. Early worsening heart failure in patients admitted for acute heart failure: time course, hemodynamic predictors, and outcome. J Card Fail. 2009;15:639–44.

    Article  PubMed  Google Scholar 

  5. Kelly JP, Mentz RJ, Hasselblad V, et al. Worsening heart failure during hospitalization for acute heart failure: insights from the acute study of clinical effectiveness of Nesiritide in decompensated heart failure (ASCEND-HF). Am Heart J. 2015;170:298–305.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Davison BA, Metra M, Cotter G, et al. Worsening heart failure following admission for acute heart failure: a pooled analysis of the PROTECT and RELAX-AHF studies. JACC Heart failure. 2015;3:395–403.

    Article  PubMed  Google Scholar 

  7. Nohria A, Tsang SW, Fang JC, et al. Clinical assessment identifies hemodynamic profiles that predict outcomes in patients admitted with heart failure. J Am Coll Cardiol. 2003;41:1797–804.

    Article  PubMed  Google Scholar 

  8. Mitchell C, Rahko PS, Blauwet LA, et al. Guidelines for performing a comprehensive transthoracic echocardiographic examination in adults: recommendations from the American Society of echocardiography. J Am Soc Echocardiogr. 2019;32:1–64.

    Article  PubMed  Google Scholar 

  9. Ristow B, Na B, Ali S, Whooley MA, Schiller NB. Left ventricular outflow tract and pulmonary artery stroke distances independently predict heart failure hospitalization and mortality: the heart and soul study. J Am Soc Echocardiogr. 2011;24:565–72.

    Article  PubMed  Google Scholar 

  10. Omote K, Nagai T, Iwano H, et al. Left ventricular outflow tract velocity time integral in hospitalized heart failure with preserved ejection fraction. ESC Heart Fail. 2020;7:168–76.

    Article  Google Scholar 

  11. Mele D, Pestelli G, Molin DD, et al. Echocardiographic evaluation of left ventricular output in patients with heart failure: A per-beat or per-minute approach? J Am Soc Echocardiogr. 2020;33(135–147):e3.

    Google Scholar 

  12. McKee PA, Castelli WP, McNamara PM, Kannel WB. The natural history of congestive heart failure: the Framingham study. N Engl J Med. 1971;285:1441–6.

    Article  CAS  PubMed  Google Scholar 

  13. Lang RM, Badano LP, Mor-Avi V, et al. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American society of echocardiography and the European association of cardiovascular imaging. J Am Soc Echocardiogr. 2015;28(1–39):e14.

    Google Scholar 

  14. Nagueh SF, Smiseth OA, Appleton CP, et al. Recommendations for the evaluation of left ventricular diastolic function by echocardiography: an update from the American society of echocardiography and the European association of cardiovascular imaging. J Am Soc Echocardiogr. 2016;29:277–314.

    Article  PubMed  Google Scholar 

  15. Baumgartner H, Hung J, Bermejo J, et al. Recommendations on the echocardiographic assessment of aortic valve stenosis: a focused update from the European association of cardiovascular imaging and the American society of echocardiography. J Am Soc Echocardiogr. 2017;30:372–92.

    Article  PubMed  Google Scholar 

  16. Peduzzi P, Concato J, Feinstein AR, Holford TR. Importance of events per independent variable in proportional hazards regression analysis. II. Accuracy and precision of regression estimates. J Clin Epidemiol. 1995;48:1503–10.

    Article  CAS  PubMed  Google Scholar 

  17. Weatherley BD, Milo-Cotter O, Felker GM, et al. Early worsening heart failure in patients admitted with acute heart failure–a new outcome measure associated with long-term prognosis? Fundam Clin Pharmacol. 2009;23:633–9.

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgements

The study will be performed by the Japanese Association of Young Echocardiography Fellows committee members: Akihiro Isotani, MD (Department of Cardiology, Kokura Memorial Hospital, Kitakyushu-city, Japan), Hiroto Utsunomiya, MD, PhD (Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan), Atsuko Furukawa, MD (Department of Cardiology, Kochi Health Sciences Center, Kochi, Japan), Masaru Obokata, MD, PhD (Department of Cardiovascular Medicine, Gunma University Hospital, Maebashi, Japan), Masahiro Yamada, MD, PhD (Department of Cardiology and Nephrology, Hirosaki University Graduate School of Medicine and School of Medicine, Hirosaki, Japan), Kotaro Nochioka, MD, PhD (Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan), Masaki Izumo, MD, PhD (Division of Cardiology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan), Toshinari Onishi MD (Cardiovascular Division, Sakurabashi Watanabe Hospital), Masahiro Yamamoto, MD, PhD (Cardiovascular Division, University of Tsukuba, Tsukuba, Japan), and Shunsuke Sasaki, MD (Division of Cardiology, Teine Keijinkai Hospital, Sapporo, Japan)

Funding

This study will be conducted as an academic project in Japanese Society of Echocardiography (JSE) and in part financially supported by JSE.

Author information

Authors and Affiliations

  1. Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 15, Nishi 7, Kita-ku, Sapporo, 060-8638, Japan

    Hiroyuki Iwano & Toshihisa Anzai

  2. Heart Center, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Japan

    Kentaro Shibayama

  3. Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan

    Takeshi Kitai

  4. Department of Cardiovascular Medicine, Tokushima University Hospital, Tokushima, Japan

    Kenya Kusunose

  5. Department of Cardiology, Himeji Cardiovascular Center, Himeji, Japan

    Tetsuari Onishi

  6. Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan

    Hidekazu Tanaka

Authors
  1. Hiroyuki Iwano
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kentaro Shibayama
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Takeshi Kitai
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Kenya Kusunose
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Tetsuari Onishi
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Hidekazu Tanaka
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Toshihisa Anzai
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

PREDICT investigators

  • Akihiro Isotani
  • , Hiroto Utsunomiya
  • , Atsuko Furukawa
  • , Masaru Obokata
  • , Masahiro Yamada
  • , Kotaro Nochioka
  • , Masaki Izumo
  • , Toshinari Onishi
  • , Masahiro Yamamoto
  •  & Shunsuke Sasaki

Corresponding author

Correspondence to Hiroyuki Iwano.

Ethics declarations

Conflict of interest

Hiroyuki Iwano, Kentaro Shibayama, Takeshi Kitai, Kenya Kusunose, Tetsuari Onishi, Hidekazu Tanaka, and Toshihisa Anzai declare that they have no conflict of interest.

Human rights statements

All procedures followed will be in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later revisions.

Informed consent

Informed consent will be obtained from all patients for being included in the study.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

The members of the PREDICT investigators are listed in the Acknowledgements section.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Iwano, H., Shibayama, K., Kitai, T. et al. Study protocol for prospect trial to elucidate the utility of echocardiography-based cardiac output in acute heart failure (PREDICT). J Echocardiogr 18, 235–239 (2020). https://doi.org/10.1007/s12574-020-00470-0

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12574-020-00470-0

Keywords

Search

Navigation