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4 Publications visible to you, out of a total of 4
DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials.

Abstract (Expand)

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).

Authors: U. Bavendiek, N. H. Thomas, D. Berliner, X. Liu, J. Schwab, A. Rieth, L. S. Maier, S. Schallhorn, E. Angelini, S. Soltani, F. Rathje, M. A. Sandu, W. Geller, T. Gaspar, R. Hambrecht, M. Zdravkovic, S. Philipp, D. Kosevic, G. Nickenig, D. Scheiber, S. Winkler, P. M. Becher, P. Lurz, M. Hulsmann, M. von Karpowitz, C. Schroder, B. Neuhaus, A. Seltmann, H. von der Leyen, C. Veltmann, S. Stork, M. Bohm, A. Koch, A. Grosshennig, J. Bauersachs

Date Published: 19th May 2025

Publication Type: Journal

The DIGIT-HF trial: Key amendments of study design.

Abstract

Not specified

Authors: U. Bavendiek, D. Berliner, N. H. Thomas, X. Liu, J. Schwab, A. Rieth, L. S. Maier, S. Schallhorn, E. Angelini, F. Rathje, M. A. Sandu, W. Geller, T. Gaspar, R. Hambrecht, M. Zdravkovic, S. Philipp, D. Kosevic, G. Nickenig, D. Scheiber, S. Winkler, P. M. Becher, P. Lurz, M. Hulsmann, C. Schroder, A. Seltmann, H. von der Leyen, C. Veltmann, S. Stork, M. Bohm, A. Koch, J. Bauersachs

Date Published: 22nd Jan 2025

Publication Type: Journal

Simple and safe digitoxin dosing in heart failure based on data from the DIGIT-HF trial.

Abstract (Expand)

BACKGROUND: The present study aimed to develop a simple dosing score when starting the cardiac glycoside digitoxin in heart failure with reduced ejection fraction (HFrEF) employing first data from the … randomized, double-blinded DIGIT-HF trial. METHODS AND RESULTS: In DIGIT-HF, digitoxin was started with a dose of 0.07 mg once daily (o.d.) in all patients. For score derivation, 317 patients were analyzed who had been randomized to digitoxin. In these patients, after scheduled determination of serum levels at study week 6, the digitoxin dose had remained unchanged or had been reduced to 0.05 mg o.d. (97% of patients) to achieve serum concentrations within a predefined range (10.5-23.6 nmol/l). In logistic regression analyses, sex, age, body mass index (BMI), and estimated glomerular filtration rate (eGFR) were associated with need for dose reduction and, therefore, selected for further developing the dosing score. Optimal cut-points were derived from ROC curve analyses. Finally, female sex, age >/= 75 years, eGFR < 50 ml/min/1.73 m(2), and BMI < 27 kg/m(2) each were assigned one point for the digitoxin dosing score. A score of >/= 1 indicated the need for dose reduction with sensitivity/specificity of 81.6%/49.7%, respectively. Accuracy was confirmed in a validation data set including 64 patients randomized to digitoxin yielding sensitivity/specificity of 87.5%/37.5%, respectively. CONCLUSION: In patients with HFrEF, treatment with digitoxin should be started at 0.05 mg o.d. in subjects with either female sex, eGFR < 50 ml/min/1.73m(2), BMI < 27 kg/m(2), or age >/= 75 years. In any other patient, digitoxin may be safely started at 0.07 mg o.d.

Authors: U. Bavendiek, A. Grosshennig, J. Schwab, D. Berliner, X. Liu, L. Maier, T. Gaspar, A. Rieth, S. Philipp, R. Hambrecht, R. Westenfeld, T. Munzel, S. Winkler, M. Hulsmann, D. Westermann, M. Zdravkovic, R. Lichtinghagen, H. von der Leyen, S. Zimmermann, C. Veltmann, M. Bohm, S. Stork, A. Koch, J. Bauersachs

Date Published: 21st Jul 2023

Publication Type: Journal

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.

Abstract (Expand)

AIMS: Despite recent advances in the treatment of chronic heart failure (HF), mortality and hospitalizations still remain high. Additional therapies to improve mortality and morbidity are urgently … needed. The efficacy of cardiac glycosides - although regularly used for HF treatment - remains unclear. DIGIT-HF was designed to demonstrate that digitoxin on top of standard of care treatment improves mortality and morbidity in patients with HF and a reduced ejection fraction (HFrEF). METHODS: Patients with chronic HF, New York Heart Association (NYHA) functional class III-IV and left ventricular ejection fraction (LVEF) </= 40%, or patients in NYHA functional class II and LVEF </= 30% are randomized 1:1 in a double-blind fashion to treatment with digitoxin (target serum concentration 8-18 ng/mL) or matching placebo. Randomization is stratified by centre, sex, NYHA functional class (II, III, or IV), atrial fibrillation, and treatment with cardiac glycosides at baseline. A total of 2190 eligible patients will be included in this clinical trial (1095 per group). All patients receive standard of care treatment recommended by expert guidelines upon discretion of the treating physician. The primary outcome is a composite of all-cause mortality or hospital admission for worsening HF (whatever occurs first). Key secondary endpoints are all-cause mortality, hospital admission for worsening HF, and recurrent hospital admission for worsening HF. CONCLUSION: The DIGIT-HF trial will provide important evidence, whether the cardiac glycoside digitoxin reduces the risk for all-cause mortality and/or hospital admission for worsening HF in patients with advanced chronic HFrEF on top of standard of care treatment.

Authors: U. Bavendiek, D. Berliner, L. A. Davila, J. Schwab, L. Maier, S. A. Philipp, A. Rieth, R. Westenfeld, C. Piorkowski, K. Weber, A. Hanselmann, M. Oldhafer, S. Schallhorn, H. von der Leyen, C. Schroder, C. Veltmann, S. Stork, M. Bohm, A. Koch, J. Bauersachs

Date Published: 21st Mar 2019

Publication Type: Journal

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