{"id":"ac8ff757b0c0","type":"article","url":"https://hartvaat.nl/2026/05/10/decision-lage-dosis-digoxine-mist-primair-eindpunt-bij-hf-m-ref-maar-suggereert-/","title":"DECISION: lage-dosis digoxine mist primair eindpunt bij HF(m)rEF, maar suggereert minder verslechterende hartfalenevents","title_en":"","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","huisarts","internist"],"tags":["acuut-hartfalen","carvedilol","dapa-hf","emperor-trials","heart-failure-2026"],"journal":"Nature Medicine","doi":"10.1038/s41591-026-04406-6","source_url":"https://doi.org/10.1038/s41591-026-04406-6","authors":["D. J. van Veldhuisen","M. Rienstra","A. Mosterd","M. Alings","A. A. Voors","K. Damman","Peter van der Meer"],"significance":9,"published":"2026-05-10","source_date":"2026-05-10","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/","https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/"],"congress":"heart-failure-2026","summary_en":"DECISION (n=1,001, 43 Dutch sites, median 36.5-month follow-up) is the first major modern RCT of low-dose digoxin in contemporary HF(m)rEF on guideline-directed therapy. The primary composite of worsening HF events plus CV mortality was lower with digoxin (RR 0.81; 95% CI 0.61–1.07) but did not reach statistical significance (p=0.133). Worsening HF events trended lower (RR 0.76); CV mortality was unchanged. Drug was well tolerated. Pooled with DIGIT-HF and DIG (n=9,013), digitalis glycosides did significantly reduce the composite (HR 0.85; p<0.001), reopening the case for digitalis as a cheap, safe add-on in HF(m)rEF.","created":"2026-07-03T10:32:53Z","updated":"2026-07-03T18:39:32Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"DECISION is de eerste grote, moderne, gerandomiseerde trial van lage-dosis digoxine bij hartfalen sinds de DIG-trial uit 1997. 1.001 Nederlandse patiënten met symptomatische HFrEF/HFmrEF (LVEF ≤50%) en richtlijntherapie werden gerandomiseerd naar lage-dosis digoxine (streefspiegel 0,5–0,9 ng/mL) of placebo en mediaan 36,5 maanden gevolgd. Het primaire eindpunt — totale verslechterende hartfalenopnames/urgente bezoeken plus cardiovasculaire sterfte — trad 238 keer op bij 131 van 500 digoxinepatiënten versus 291 keer bij 152 van 501 placebopatiënten (rate ratio 0,81; 95% BI 0,61–1,07; p=0,133): geen statistische significantie. Verslechterende hartfalenevents waren lager in de digoxinegroep (RR 0,76; 95% BI 0,54–1,05); cardiovasculaire sterfte was vergelijkbaar (HR 0,93). Lage-dosis digoxine was goed verdraagbaar. Conclusie: het primaire eindpunt werd gemist, maar de richting bevestigt het signaal uit DIGIT-HF. In een gepoolde meta-analyse met DIGIT-HF en DIG (n=9.013) bereikten digitalisglycosiden wél significantie (HR 0,85). Goedkope, veilige optie die — gelet op het volume aan ondersteunend bewijs — herziening van richtlijnpositie verdient.","abstract_original":"BACKGROUND: The benefit of low-dose digoxin in contemporary patients with heart failure with reduced or mildly reduced ejection fraction (HF(m)rEF) treated according to current guidelines is unclear. METHODS: DECISION was a double-blind, randomized, placebo-controlled outcome trial conducted at 43 Dutch sites enrolling 1001 patients with symptomatic mild-to-moderate HF(m)rEF (LVEF ≤50%). Mean age was 73 years, 28% were women, and 29% had atrial fibrillation. Patients were randomized 1:1 to low-dose digoxin (target serum concentration 0.5–0.9 ng/mL) or matching placebo on top of guideline-directed medical therapy. The primary endpoint was a composite of total worsening heart failure events (hospitalizations or urgent visits) and cardiovascular mortality. Median follow-up was 36.5 months. RESULTS: The primary endpoint occurred 238 times in 131 of 500 digoxin patients versus 291 times in 152 of 501 placebo patients (rate ratio 0.81; 95% CI 0.61–1.07; p=0.133). Total worsening heart failure events were lower in the digoxin group (RR 0.76; 95% CI 0.54–1.05). Cardiovascular mortality was similar (HR 0.93; 95% CI 0.69–1.26). Low-dose digoxin was generally well tolerated and safe. CONCLUSIONS: Low-dose digoxin did not significantly reduce the composite of worsening heart failure events and cardiovascular mortality in contemporary HF(m)rEF, although directional benefit on worsening heart failure events was observed."}