DIGitoxin to Improve Outcomes in Patients with Advanced Chronic Heart Failure (DIGIT-HF): Baseline Characteristics Compared to Recent Randomized Controlled Heart Failure Trials
Udo Bavendiek, Nele Henrike Thomas, Dominik Berliner, Xiaofei Liu, Johannes Schwab, Andreas Rieth, Lars S. Maier, Sven Schallhorn, Eleonora Angelini, Samira Soltani, Fabian Rathje, Mircea‐Andrei Sandu, Welf Geller, Thomas Gaspar, Rainer Hambrecht, Marija Zdravković, Sebastian Philipp, Dragana Kosevic, Georg Nickenig, Daniel Scheiber, Sebastian Winkler, Peter Moritz Becher, Philipp Lurz, Martin Hülsmann, Maria von Karpowitz, Christoph Schröder, Barbara Neuhaus, Anika Seltmann, Heiko von der Leyen, Christian Veltmann, Stefan Störk, Michael Böhm, Armin Koch, Anika Großhennig, Johann Bauersachs, the DIGIT-HF Study Group
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).