DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials

the DIGIT-HF Study Group

doi:10.1002/ejhf.3679

DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials

the DIGIT-HF Study Group

Medizinische Klinik II

9 Zitate (Scopus)

Abstract

Aims: This report presents the baseline characteristics of patients enrolled in the DIGIT-HF trial and compares them with participants from recent trials with improved outcomes in patients with heart failure (HF) and a reduced ejection fraction (HFrEF). Methods and results: DIGIT-HF, a randomized, double-blind, placebo-controlled, multicentre trial enrolling patients with symptomatic HFrEF (New York Heart Association [NYHA] functional class II and left ventricular ejection fraction [LVEF] ≤30%, or NYHA class III–IV and LVEF ≤40%), compares the efficacy and safety of digitoxin versus placebo in addition to standard treatment. Most baseline characteristics of the intention-to-treat population (1212 patients, mean age 66 ± 11 years, 20% women, mean LVEF 29 ± 7%) were similar to those in recent HFrEF trials. The distribution of NYHA class II, III, and IV was 30%, 66% and 4%, respectively, and indicates that the patients were sicker than in comparator HFrEF trials. Less patients had atrial fibrillation (27%) than those in recent HFrEF trials, but prescription rates of background therapy with beta-blockers (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor–neprilysin inhibitors (95%), mineralocorticoid receptor antagonists (76%), and diuretics (87%) were high and similar. Overall, 40% of patients were on angiotensin receptor–neprilysin inhibitors, 19% on sodium–glucose cotransporter 2 inhibitors, and 9% on ivabradine. Rates of implantable cardioverter-defibrillator (ICD, 64%) and cardiac resynchronization therapy (CRT, 25%) devices were much higher than in recent HFrEF trials. Conclusions: Patients included in DIGIT-HF display a more severe HF symptom burden and higher rates of ICD/CRT implants compared to participants in recent HFrEF trials, while pharmacotherapy was largely similar. Clinical Trial Registration: EudraCT (2013–005326-38).

Originalsprache	Englisch
Zeitschrift	European Journal of Heart Failure
Jahrgang	27
Ausgabenummer	7
Seiten (von - bis)	1224-1233
Seitenumfang	10
ISSN	1388-9842
DOIs	https://doi.org/10.1002/ejhf.3679
Publikationsstatus	Veröffentlicht - 01.2025

Fördermittel

The trial is supported by the German Federal Ministry of Education and Research (BMBF) under grant number 01KG1303/01KG1907 and the Braukmann Wittenberg Heart Foundation as well as the German Heart Foundation. : U.B. and J.B. represent the study heads of the DIGIT‐HF study and applied for funding of DIGIT‐HF described above. U.B., J.B., A.K., H.v.d.L., C.V., S.S., and M.B. are members of the DIGIT‐HF trial Steering Committee. U.B. received travel support and honoraria for lectures/consulting from Alnylam Pharmaceutical, Amgen, AstraZeneca, Bayer Vital, Lilly, Novartis, and Pfizer, and institutional research support from Alnylam Pharmaceuticals, all not related to this article. D.B. was competitively selected for ‘CORE100Pilot’, which is an advanced clinician–scientist programme co‐funded by the Else Kröner Fresenius Foundation and the Ministry for Science and Culture of the State of Lower Saxony. D.B. received honoraria for lectures/consulting from Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Pfizer, all not related to this article. P.M.B reports personal fees from AstraZeneca, Ingelheim Boehringer and the German Research Foundation, all not related to this article. C.V. reports honoraria for lectures or consulting from Abbott, Medtronic, BMS and Zoll, all not related to this article. M.B. is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939) and reports personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Edwards, Medtronic, Novartis, ReCor, Servier and Vifor during the conduct of the study. J.B. received honoraria for lectures/consulting from Novartis, Abbott, Bayer, Pfizer, Boehringer Ingelheim, AstraZeneca, Cardior, CVRx, BMS, Amgen, Edwards, Roche, Zoll, not related to this article; and research support for the department from Zoll, CVRx, Abiomed, Norgine, Roche, all not related to this article. All other authors have nothing to disclose. Conflict of interest

Träger	Trägernummer
Deutsche Herzstiftung
AstraZeneca
Cytokinetics
Novartis
Servier and Vifor
Boehringer Ingelheim
Braukmann Wittenberg Heart Foundation
Medtronic
Deutsche Forschungsgemeinschaft
Bayer
Bundesministerium für Bildung und Forschung	01KG1303/01KG1907
German Research Foundation	TTR 219, 322900939

UN SDGs

Dieser Output leistet einen Beitrag zu folgendem(n) Ziel(en) für nachhaltige Entwicklung

SDG 3 – Gesundheit und Wohlergehen

Strategische Forschungsbereiche und Zentren

Zentren: Universitäres Herzzentrum Lübeck (UHZL)

DFG-Fachsystematik

2.22-12 Kardiologie, Angiologie

Dokumente

10.1002/ejhf.3679

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@article{9988e40c343a4535bc88892e8ab4248e,

title = "DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials",

abstract = "Aims: This report presents the baseline characteristics of patients enrolled in the DIGIT-HF trial and compares them with participants from recent trials with improved outcomes in patients with heart failure (HF) and a reduced ejection fraction (HFrEF). Methods and results: DIGIT-HF, a randomized, double-blind, placebo-controlled, multicentre trial enrolling patients with symptomatic HFrEF (New York Heart Association [NYHA] functional class II and left ventricular ejection fraction [LVEF] ≤30\%, or NYHA class III–IV and LVEF ≤40\%), compares the efficacy and safety of digitoxin versus placebo in addition to standard treatment. Most baseline characteristics of the intention-to-treat population (1212 patients, mean age 66 ± 11 years, 20\% women, mean LVEF 29 ± 7\%) were similar to those in recent HFrEF trials. The distribution of NYHA class II, III, and IV was 30\%, 66\% and 4\%, respectively, and indicates that the patients were sicker than in comparator HFrEF trials. Less patients had atrial fibrillation (27\%) than those in recent HFrEF trials, but prescription rates of background therapy with beta-blockers (96\%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor–neprilysin inhibitors (95\%), mineralocorticoid receptor antagonists (76\%), and diuretics (87\%) were high and similar. Overall, 40\% of patients were on angiotensin receptor–neprilysin inhibitors, 19\% on sodium–glucose cotransporter 2 inhibitors, and 9\% on ivabradine. Rates of implantable cardioverter-defibrillator (ICD, 64\%) and cardiac resynchronization therapy (CRT, 25\%) devices were much higher than in recent HFrEF trials. Conclusions: Patients included in DIGIT-HF display a more severe HF symptom burden and higher rates of ICD/CRT implants compared to participants in recent HFrEF trials, while pharmacotherapy was largely similar. Clinical Trial Registration: EudraCT (2013–005326-38).",

author = "\{the DIGIT-HF Study Group\} and Udo Bavendiek and Thomas, \{Nele Henrike\} and Dominik Berliner and Xiaofei Liu and Johannes Schwab and Andreas Rieth and Maier, \{Lars S.\} and Sven Schallhorn and Eleonora Angelini and Samira Soltani and Fabian Rathje and Sandu, \{Mircea Andrei\} and Welf Geller and Thomas Gaspar and Rainer Hambrecht and Marija Zdravkovic and Sebastian Philipp and Dragana Kosevic and Georg Nickenig and Daniel Scheiber and Sebastian Winkler and Becher, \{Peter Moritz\} and Philipp Lurz and Martin H{\"u}lsmann and \{von Karpowitz\}, Maria and Christoph Schr{\"o}der and Barbara Neuhaus and Anika Seltmann and \{von der Leyen\}, Heiko and Christian Veltmann and Stefan St{\"o}rk and Michael B{\"o}hm and Armin Koch and Anika Gro{\ss}hennig and Johann Bauersachs and Udo Bavendiek and Johann Bauersachs and Christoph Schindler and Armin Koch and Stichtenoth, \{Dirk O.\} and Udo Bavendiek and Johann Bauersachs and Christian Veltmann and Michael B{\"o}hm and Harm Wienbergen and Holger Thiele and Tobias Graf and Reil, \{Jan Christian\} and Stefan Rausch and Kyrill Rogacev",

note = "Publisher Copyright: {\textcopyright} 2025 The Author(s). European Journal of Heart Failure published by John Wiley \& Sons Ltd on behalf of European Society of Cardiology.",

year = "2025",

month = jan,

doi = "10.1002/ejhf.3679",

language = "English",

volume = "27",

pages = "1224--1233",

journal = "European Journal of Heart Failure",

issn = "1388-9842",

publisher = "Oxford University Press",

number = "7",

}

DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials. / the DIGIT-HF Study Group.
in: European Journal of Heart Failure, Jahrgang 27, Nr. 7, 01.2025, S. 1224-1233.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF)

T2 - Baseline characteristics compared to recent randomized controlled heart failure trials

AU - the DIGIT-HF Study Group

AU - Bavendiek, Udo

AU - Thomas, Nele Henrike

AU - Berliner, Dominik

AU - Liu, Xiaofei

AU - Schwab, Johannes

AU - Rieth, Andreas

AU - Maier, Lars S.

AU - Schallhorn, Sven

AU - Angelini, Eleonora

AU - Soltani, Samira

AU - Rathje, Fabian

AU - Sandu, Mircea Andrei

AU - Geller, Welf

AU - Gaspar, Thomas

AU - Hambrecht, Rainer

AU - Zdravkovic, Marija

AU - Philipp, Sebastian

AU - Kosevic, Dragana

AU - Nickenig, Georg

AU - Scheiber, Daniel

AU - Winkler, Sebastian

AU - Becher, Peter Moritz

AU - Lurz, Philipp

AU - Hülsmann, Martin

AU - von Karpowitz, Maria

AU - Schröder, Christoph

AU - Neuhaus, Barbara

AU - Seltmann, Anika

AU - von der Leyen, Heiko

AU - Veltmann, Christian

AU - Störk, Stefan

AU - Böhm, Michael

AU - Koch, Armin

AU - Großhennig, Anika

AU - Bauersachs, Johann

AU - Bavendiek, Udo

AU - Bauersachs, Johann

AU - Schindler, Christoph

AU - Koch, Armin

AU - Stichtenoth, Dirk O.

AU - Bavendiek, Udo

AU - Bauersachs, Johann

AU - Veltmann, Christian

AU - Böhm, Michael

AU - Wienbergen, Harm

AU - Thiele, Holger

AU - Graf, Tobias

AU - Reil, Jan Christian

AU - Rausch, Stefan

AU - Rogacev, Kyrill

PY - 2025/1

Y1 - 2025/1

N2 - Aims: This report presents the baseline characteristics of patients enrolled in the DIGIT-HF trial and compares them with participants from recent trials with improved outcomes in patients with heart failure (HF) and a reduced ejection fraction (HFrEF). Methods and results: DIGIT-HF, a randomized, double-blind, placebo-controlled, multicentre trial enrolling patients with symptomatic HFrEF (New York Heart Association [NYHA] functional class II and left ventricular ejection fraction [LVEF] ≤30%, or NYHA class III–IV and LVEF ≤40%), compares the efficacy and safety of digitoxin versus placebo in addition to standard treatment. Most baseline characteristics of the intention-to-treat population (1212 patients, mean age 66 ± 11 years, 20% women, mean LVEF 29 ± 7%) were similar to those in recent HFrEF trials. The distribution of NYHA class II, III, and IV was 30%, 66% and 4%, respectively, and indicates that the patients were sicker than in comparator HFrEF trials. Less patients had atrial fibrillation (27%) than those in recent HFrEF trials, but prescription rates of background therapy with beta-blockers (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor–neprilysin inhibitors (95%), mineralocorticoid receptor antagonists (76%), and diuretics (87%) were high and similar. Overall, 40% of patients were on angiotensin receptor–neprilysin inhibitors, 19% on sodium–glucose cotransporter 2 inhibitors, and 9% on ivabradine. Rates of implantable cardioverter-defibrillator (ICD, 64%) and cardiac resynchronization therapy (CRT, 25%) devices were much higher than in recent HFrEF trials. Conclusions: Patients included in DIGIT-HF display a more severe HF symptom burden and higher rates of ICD/CRT implants compared to participants in recent HFrEF trials, while pharmacotherapy was largely similar. Clinical Trial Registration: EudraCT (2013–005326-38).

AB - Aims: This report presents the baseline characteristics of patients enrolled in the DIGIT-HF trial and compares them with participants from recent trials with improved outcomes in patients with heart failure (HF) and a reduced ejection fraction (HFrEF). Methods and results: DIGIT-HF, a randomized, double-blind, placebo-controlled, multicentre trial enrolling patients with symptomatic HFrEF (New York Heart Association [NYHA] functional class II and left ventricular ejection fraction [LVEF] ≤30%, or NYHA class III–IV and LVEF ≤40%), compares the efficacy and safety of digitoxin versus placebo in addition to standard treatment. Most baseline characteristics of the intention-to-treat population (1212 patients, mean age 66 ± 11 years, 20% women, mean LVEF 29 ± 7%) were similar to those in recent HFrEF trials. The distribution of NYHA class II, III, and IV was 30%, 66% and 4%, respectively, and indicates that the patients were sicker than in comparator HFrEF trials. Less patients had atrial fibrillation (27%) than those in recent HFrEF trials, but prescription rates of background therapy with beta-blockers (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor–neprilysin inhibitors (95%), mineralocorticoid receptor antagonists (76%), and diuretics (87%) were high and similar. Overall, 40% of patients were on angiotensin receptor–neprilysin inhibitors, 19% on sodium–glucose cotransporter 2 inhibitors, and 9% on ivabradine. Rates of implantable cardioverter-defibrillator (ICD, 64%) and cardiac resynchronization therapy (CRT, 25%) devices were much higher than in recent HFrEF trials. Conclusions: Patients included in DIGIT-HF display a more severe HF symptom burden and higher rates of ICD/CRT implants compared to participants in recent HFrEF trials, while pharmacotherapy was largely similar. Clinical Trial Registration: EudraCT (2013–005326-38).

UR - https://www.scopus.com/pages/publications/105005962433

UR - https://www.mendeley.com/catalogue/a6521be1-306c-38ac-9169-4e1c22fcd1eb/

U2 - 10.1002/ejhf.3679

DO - 10.1002/ejhf.3679

M3 - Journal articles

C2 - 40389288

AN - SCOPUS:105005962433

SN - 1388-9842

VL - 27

SP - 1224

EP - 1233

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

IS - 7

ER -

DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials

Abstract

Fördermittel

UN SDGs

Strategische Forschungsbereiche und Zentren

DFG-Fachsystematik

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