DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials.
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Bavendiek Udo, Thomas Nele Henrike, Berliner Dominik, Liu Xiaofei, Schwab Johannes, Rieth Andreas, Maier Lars S, Schallhorn Sven, Angelini Eleonora, Soltani Samira, Rathje Fabian, Sandu Mircea-Andrei, Geller Welf, Gaspar Thomas, Hambrecht Rainer, Zdravkovic Marija, Philipp Sebastian, Kosevic Dragana, Nickenig Georg, Scheiber Daniel, Winkler Sebastian, Becher Peter Moritz, Lurz Philipp, Hülsmann Martin, von Karpowitz Maria, Schröder Christoph, Neuhaus Barbara, Seltmann Anika, von der Leyen Heiko, Veltmann Christian, Störk Stefan, Böhm Michael, Koch Armin, Großhennig Anika, Bauersachs Johann, DIGIT‐HF Study Group
Аннотация
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).