Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Mar;27(3):606-608.
doi: 10.1002/ejhf.3575. Epub 2025 Jan 21.

The DIGIT-HF trial: Key amendments of study design

Udo Bavendiek  1 , Dominik Berliner  1 , Nele Henrike Thomas  2 , Xiaofei Liu  2 , Johannes Schwab  3   4 , Andreas Rieth  5 , Lars S Maier  6 , Sven Schallhorn  1 , Eleonora Angelini  1 , Fabian Rathje  1 , Mircea-Andrei Sandu  1 , Welf Geller  1 , Thomas Gaspar  7 , Rainer Hambrecht  8 , Marija Zdravkovic  9 , Sebastian Philipp  10 , Dragana Kosevic  11 , Georg Nickenig  12 , Daniel Scheiber  13 , Sebastian Winkler  14 , Peter Moritz Becher  15   16 , Philipp Lurz  17 , Martin Hülsmann  18 , Christoph Schröder  19 , Anika Seltmann  20 , Heiko von der Leyen  21   22 , Christian Veltmann  1   23 , Stefan Störk  24 , Michael Böhm  25 , Armin Koch  2 , Johann Bauersachs  1
Affiliations

The DIGIT-HF trial: Key amendments of study design

Udo Bavendiek et al. Eur J Heart Fail. 2025 Mar.
No abstract available

PubMed Disclaimer

Figures

Figure 1
Figure 1
Summary of key protocol changes during the DIGIT‐HF trial. ACEi, angiotensin‐converting enzyme inhibitor; ARNI, angiotensin receptor–neprilysin inhibitor; AT1‐RB, angiotensin 1 receptor blocker; BB, beta‐blocker; CRT, cardiac resynchronization therapy; ICD, implantable cardiac defibrillator; MRA, mineralocorticoid receptor antagonist; SGLT2i, sodium–glucose cotransporter 2 inhibitor; WHF, worsening heart failure.
See this image and copyright information in PMC

References

    1. Bavendiek U, Berliner D, Davila LA, Schwab J, Maier L, Philipp SA, et al. Rationale and design of the DIGIT‐HF trial (DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure): A randomized, double‐blind, placebo‐controlled study. Eur J Heart Fail 2019;21:676–684. 10.1002/ejhf.1452 - DOI - PMC - PubMed
    1. van Veldhuisen DJ, Bauersachs J. Digitalis in heart failure: Declining use and ongoing outcome trials. Eur Heart J 2023;44:1976–1978. 10.1093/eurheartj/ehad185 - DOI - PubMed
    1. McMurray JJV, Solomon SD, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, et al.; DAPA‐HF Trial Committees and Investigators . Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med 2019;381:1995–2008. 10.1056/NEJMoa1911303 - DOI - PubMed
    1. Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, et al.; EMPEROR‐Reduced Trial Investigators . Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med 2020;383:1413–1424. 10.1056/NEJMoa2022190 - DOI - PubMed
    1. Fritsch A, Schlömer P, Mendolia F, Mütze T, Jahn‐Eimermacher A. Efficiency comparison of analysis methods for recurrent event and time‐to‐first event endpoints in the presence of terminal events – application to clinical trials in chronic heart failure. Stat Biopharm Res 2021;15:268–279. 10.1080/19466315.2021.1945488 - DOI