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DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics
Udo Bavendiek1, Nele Henrike Thomas2, Dominik Berliner1
1Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
Insights
The DIGIT-HF trial enrolled patients with heart failure and reduced ejection fraction (HFrEF) who had more severe symptoms and higher rates of device implants than those in recent trials. Pharmacotherapy use was similar across studies.
Area of Science:
- Cardiology
- Clinical Trials
- Heart Failure Research
Background:
- The DIGIT-HF trial investigates digitoxin efficacy in heart failure with reduced ejection fraction (HFrEF).
- Understanding baseline patient characteristics is crucial for interpreting trial results and comparing them to existing literature.
Purpose of the Study:
- To present the baseline characteristics of patients in the DIGIT-HF trial.
- To compare these characteristics with participants from recent HFrEF trials that reported improved outcomes.
Main Methods:
- DIGIT-HF is a randomized, double-blind, placebo-controlled, multicenter trial.
- Patients with symptomatic HFrEF (NYHA class II-IV, LVEF ≤30-40%) were enrolled.
- Baseline demographics, clinical status, and medication/device use were analyzed.
Main Results:
- The DIGIT-HF population (1212 patients) had a mean age of 66 years, 20% women, and mean LVEF of 29%.
- Patients presented with more severe symptoms (NYHA class II-IV distribution: 30%, 66%, 4%) compared to recent HFrEF trials.
- High rates of guideline-directed medical therapy (GDMT) were observed, with 96% on beta-blockers and 95% on ACEi/ARBs/ARNIs.
- Implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) device implantation rates were notably higher (64% and 25%, respectively).
Conclusions:
- Patients in DIGIT-HF exhibited a greater symptom burden and higher device utilization than those in comparator HFrEF trials.
- Pharmacotherapy regimens were comparable to those in recent trials, suggesting a focus on device therapy in this cohort.
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).
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