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Point-of-care B-type natriuretic peptide and portable echocardiography for assessment of patients with suspected heart failure in primary care: rationale and design of the three-part Handheld-BNP program and results of the training study

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Abstract

Background

Patients with suspected heart failure (HF) often present first to general practitioners (GPs). Timely and accurate HF diagnosis and reliable prognostic information have remained unmet goals in primary care, where patient evaluation often relies on clinical assessment only. The Handheld-BNP program investigates whether additional use of portable echocardiography (ECHO) and point-of-care determination of B-type natriuretic peptide (BNP) improves the accuracy of HF diagnosis and aids risk prediction in primary care.

Methods and results

A research network was established between 2 academic centers, 2 × 6 cardiologists, and 2 × 24 GPs inexperienced with ECHO and BNP. The Training Study investigates the feasibility of implementing GP use and interpretation of ECHO and BNP. After training, competence is assessed using multiple-choice testing (pass mark: > 80% correct diagnoses). In the cluster-randomized four-arm Screening Study, each GP passes in random order through four study arms: clinical assessment (CA), CA + BNP, CA + ECHO, and CA + ECHO + BNP. Cardiologists’ diagnoses serve as reference. Primary endpoint is the rate of correct GP diagnoses per study arm. In the Prognostic Follow-Up Study, patients are followed up centrally for 72 months. Forty-four GPs were successfully trained. With 225 ± 34 (75 ± 3) and 233 ± 28 (81 ± 7) min, respectively, total ECHO (BNP) training times were similar between centers I and II. Furthermore, training results did not differ between centers.

Conclusions

Standardized training of limited duration enabled GPs to use ECHO and BNP for HF diagnosis. The Handheld-BNP program will provide robust evaluation of the diagnostic effectiveness and prognostic value of these tools in primary care.

Trial Registration

http://www.controlled-trials.com (ISRCTN23325295).

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Acknowledgements

The authors thank all general practitioners and cardiologists contributing to the Handheld-BNP program. General practitioners receive honoraria for patient enrolment and follow-up (€200 per randomized patient for enrolment visit, completion of case report form and delivery of biomaterials, and €20 per completed of follow-up case report form). Cardiologists receive honoraria for expert patient assessment (€200 per patient for baseline heart failure diagnosis and completion of case report form). The authors also thank patients willing to participate in the Handheld-BNP program. Patients are not compensated for study participation. The authors wish to especially thank Prof. Dr. Goetz Gelbrich (Institute for Clinical Epidemiology and Biometry, University of Würzburg) for statistical advice, Monika Hanke for supervision and quality control of data collection, and Robert Wenzl for expert graphical design of the figures. The authors also thank the clinical research teams at both study centers, and the study and data managers at the Clinical Trial Center Leipzig and at the Comprehensive Heart Failure Center, Würzburg. English language editing support was provided by Nicola Ryan, BSc, independent medical writer, supported by the University of Würzburg. The Handheld-BNP program is funded in the frame of the Competence Network Heart Failure by the Federal Ministry of Education and Research (BMBF), Germany (BMBF, Grants 01GI0205 and 01GI1202A). Equipment and test kits for BNP point-of-care testing are provided by Biosite Diagnostics GmbH, Gießerallee 31, 47877 Willich (now Alere Technologies GmbH, Löbstedter Str. 103–105 07749 Jena). Ultrasound equipment is provided by Philips Medizinsysteme Ultraschall, Röntgenstr. 24, 22335 Hamburg.

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Authors and Affiliations

  1. Comprehensive Heart Failure Center, University and Department of Medicine I, Cardiology, University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany

    Caroline Morbach, Stefan Störk, Georg Ertl & Christiane E. Angermann

  2. Department of Angiology and Cardiology, University Hospital Essen, Essen, Germany

    Thomas Buck & Raimund Erbel

  3. Department of Cardiology, Heart Center Westfalen, Klinikum Westfalen, Dortmund, Germany

    Thomas Buck

  4. Department of Medicine I, University Hospital Würzburg, Würzburg, Germany

    Christian Rost, Sebastian Peter & Stephan Günther

  5. Cardiological Practice, Ludwigstr. 29, 97070, Würzburg, Germany

    Christian Rost

  6. Kitzinger Land Hospital, Kitzingen, Germany

    Sebastian Peter

  7. Barmherzige Brüder Hospital, Regensburg, Germany

    Stephan Günther

  8. Clinical Trial Center Leipzig, University of Leipzig, Leipzig, Germany

    Christiane Prettin

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  6. Stefan Störk
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  7. Christiane Prettin
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  8. Raimund Erbel
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  9. Georg Ertl
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  10. Christiane E. Angermann
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On Behalf of the Handheld-BNP Research Network

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Correspondence to Christiane E. Angermann.

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Conflict of interest

Dr. Störk reported receiving grants from the Federal Ministry for Education and Research, Boehringer, and Santhera; grants and personal fees from Servier, Pfizer, Novartis, Roche Diagnostics, and Thermo Fisher/Brahms; and personal fees from AstraZeneca, Genzyme, Medtronic, and Bayer. Dr. Ertl reported receiving grants from the German Ministry of Education and Research; and grants and personal fees Novartis and Boehringer Ingelheim. Dr. Angermann reported receiving funding for the Handheld-BNP program in the frame of the Competence Network Heart Failure by the Federal Ministry of Education and Research (Grants 01GI0205 and 01GI1202A) and nonfinancial support of the Handheld-BNP program from Biosite Diagnostics (now Alere Technologies), Germany, and Philips Medizinsysteme Ultraschall, Germany. Outside the current project, Dr. Angermann reported grants, personal fees, nonfinancial support, and other from ResMed; grants, personal fees, and other from Novartis; grants and nonfinancial support from Thermo Fisher; grants and personal fees from Boehringer and Vifor; nonfinancial support from the University Hospital Würzburg and the Comprehensive Heart Failure Center Würzburg; and grant support from the German Ministry for Education and Research. All other authors state that they have no conflicts of interest to declare.

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Morbach, C., Buck, T., Rost, C. et al. Point-of-care B-type natriuretic peptide and portable echocardiography for assessment of patients with suspected heart failure in primary care: rationale and design of the three-part Handheld-BNP program and results of the training study. Clin Res Cardiol 107, 95–107 (2018). https://doi.org/10.1007/s00392-017-1181-3

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