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Novel Trial Designs in Heart Failure: Using Digital Health Tools to Increase Pragmatism

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Abstract

Purpose of Review

Heart failure is an important clinical and public health issue. There is an urgent need to improve the efficiency of clinical trials in heart failure to rapidly identify new therapies and evidence-based implementation strategies for currently existing therapies. Electronic health (eHealth) platforms and digital health tools are being integrated into heart failure care. In this manuscript, we review opportunities to use these tools to potentially improve the design of and reduce the complexity of clinical trials in heart failure.

Recent Findings

The PRECIS-2 tool outlines clinical trial design domains that are targets for pragmatism. We believe incorporating pragmatic design elements with the aid of eHealth platforms and digital health tools into clinical trials may help address the current complexity of clinical trials in heart failure and improve efficiency. In the manuscript, we provide examples from recent clinical trials across clinical trial design domains.

Summary

We believe the current adoption of eHealth platforms and digital health tools is an opportunity improve the design of heart failure clinical trials. We specifically believe these tools can enhance pragmatism in clinical trials and reduce delays in generating high-quality evidence for new heart failure therapeutics.

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Author information

Authors and Affiliations

  1. Department of Medicine, Duke University School of Medicine, 200 Trent Drive, 4th Floor, Orange Zone, Room #4225, Durham, NC, 27710, USA

    Adam D. DeVore & Marat Fudim

  2. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA

    Adam D. DeVore & Marat Fudim

  3. Karolinska Institutet, Department of Medicine, Unit of Cardiology, Stockholm, Sweden

    Lars H. Lund

  4. Karolinska University Hospital, Heart and Vascular Theme, Stockholm, Sweden

    Lars H. Lund

Authors
  1. Adam D. DeVore
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  2. Marat Fudim
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  3. Lars H. Lund
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Contributions

The first draft of the manuscript was written by the first author and all authors critically reviewed and revised the manuscript.

Corresponding author

Correspondence to Adam D. DeVore.

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Conflict of Interest

The following relationships exist related to this manuscript:

Adam DeVore reports research funding through his institution from Biofourmis, Bodyport, Cytokinetics, American Regent, Inc, the NIH and NHLBI, Novartis, and Story Health. He also provides consulting services for and/or receives honoraria from Abiomed, Cardionomic, LivaNova, Natera, NovoNordisk, Story Health, and Zoll.

Marat Fudim received consulting fees from Abbott, Ajax, Alio Health, Alleviant, Artha, Audicor, AxonTherapies, Bayer, Bodyguide, Bodyport, Boston Scientific, Broadview, Cadence, Cardioflow, Cardionomics, Coridea, CVRx, Daxor, Deerfield Catalyst, Edwards LifeSciences, Echosens, EKO, Feldschuh Foundation, Fire1, FutureCardia, Galvani, Gradient, Hatteras, HemodynamiQ, Impulse Dynamics, Intershunt, Medtronic, Merck, NIMedical, NovoNordisk, NucleusRx, NXT Biomedical, Orchestra, Pharmacosmos, PreHealth, Presidio, Procyreon, ReCor, Rockley, SCPharma, Shifamed, Splendo, Summacor, SyMap, Verily, Vironix, Viscardia, Zoll.

Lars Lund reports: Grants, consulting, honoraria: Abbot, Alleviant, AstraZeneca, Bayer, Biopeutics, Boehringer Ingelheim, Edwards, Merck/MSD, Novartis, Novo Nordisk, OrionPharma, Owkin, Pharmacosmos, Vifor Pharma; Stock ownership: AnaCardio.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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DeVore, A.D., Fudim, M. & Lund, L.H. Novel Trial Designs in Heart Failure: Using Digital Health Tools to Increase Pragmatism. Curr Heart Fail Rep 21, 5–10 (2024). https://doi.org/10.1007/s11897-023-00640-y

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  • DOI: https://doi.org/10.1007/s11897-023-00640-y

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